Class II Recall

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers

Summary

The FDA issued a Class II for Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 72 by Philips North America Llc. Reason: Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a .

Details

Source

Device Recall

External ID

Z-0874-2022

Action Date

2022-04-13

Status

Ongoing

Product Description

Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

Lot/Code Info: UDI: (01)00884838059030(21)839 (01)00884838085275(21)131 (01)00884838059054(21)577 (01)00884838085350(21)81 (01)00884838085367(21)271 (01)00884838054202(21)879 (01)00884838054202(21)1783 (01)00884838054202(21)1447 (01)00884838099241(21)282 (01)00884838099258(21)512 (01)00884838099258(21)360 (01)00884838099258(21)370 (01)00884838099258(21)584 (01)00884838099272(21)239 (01)00884838099258(21)425 (01)00884838099258(21)232 (01)00884838099258(21)591 (01)00884838099258(21)580 (01)00884838099258(21)39 (01)00884838099241(21)198 (01)00884838099258(21)589 (01)00884838099258(21)362 (01)00884838085268(21)954 (01)00884838099234(21)10 (01)00884838099241(21)214 (01)00884838099272(21)183 (01)00884838099258(21)526 (01)00884838099258(21)441 (01)00884838099272(21)121 (01)00884838099258(21)80 (01)00884838099258(21)326 (01)00884838099258(21)518 (01)00884838099258(21)404 (01)00884838099241(21)252 (01)00884838099258(21)453 (01)00884838099258(21)472 (01)00884838099258(21)465 (01)00884838099272(21)129 (01)00884838099272(21)174 (01)00884838099258(21)553 (01)00884838099258(21)517 (01)00884838099258(21)400 (01)00884838099258(21)342 (01)00884838099258(21)582 (01)00884838099241(21)196 (01)00884838085268(21)1391 (01)00884838099258(21)485 (01)00884838099258(21)262 (01)00884838099258(21)277 (01)00884838099272(21)120 (01)00884838085268(21)703826 (01)00884838085367(21)38 (01)00884838085367(21)36 (01)00884838085275(21)139 (01)00884838085268(21)1199 (01)00884838085251(21)940 (01)00884838085251(21)945 (01)00884838085251(21)947 (01)00884838085268(21)703680 (01)00884838085251(21)964 (01)00884838085268(21)703724 (01)00884838085268(21)703541 (01)00884838085268(21)703815 (01)00884838085251(21)991 (01)00884838085251(21)1013 (01)00884838085251(21)943 (01)00884838085251(21)1025 (01)00884838085282(21)417 (01)00884838054202(21)511 (01)00884838085268(21)559 (01)00884838085268(21)560 (01)00884838085268(21)340 (01)00884838085350(21)45 (01)00884838085268(21)703560 (01)00884838054202(21)810 (01)00884838085350(21)272 (01)00884838085350(21)256 (01)00884838054189(21)364 (01)00884838054189(21)164 (01)00884838054189(21)1250 (01)00884838059030(21)226 (01)00884838059030(21)860 (01)00884838054189(21)1105 (01)00884838085251(21)464 (01)00884838085268(21)703523 (01)00884838085268(21)703524 (01)00884838085268(21)1418 (01)00884838085268(21)1209 (01)00884838085268(21)1427 (01)00884838085268(21)703537 (01)00884838085268(21)703538 (01)00884838085268(21)703517 (01)00884838085268(21)1426 (01)00884838054202(21)305 (01)00884838054196(21)139 (01)00884838085251(21)1003 (01)00884838085251(21)207 (01)00884838085251(21)209 (01)00884838085251(21)211 (01)00884838085251(21)447 (01)00884838085268(21)232 (01)00884838054189(21)412 (01)00884838054202(21)1547 (01)00884838054219(21)59 (01)00884838054240(21)92 (01)00884838085251(21)1005 (01)00884838085251(21)220 (01)00884838085251(21)799 (01)00884838099258(21)221 (01)00884838099227(21)62 (01)00884838099241(21)201 (01)00884838099241(21)185 (01)00884838099258(21)145 (01)00884838099258(21)257 (01)00884838099258(21)352 (01)00884838099258(21)353 (01)00884838099272(21)141 (01)00884838099258(21)368 (01)00884838099241(21)132 (01)00884838099241(21)165 (01)00884838099241(21)117 (01)00884838099241(21)195 (01)00884838099258(21)555 (01)00884838099241(21)267 (01)00884838099241(21)268 (01)00884838099241(21)271 (01)00884838099241(21)270 (01)00884838099241(21)255 (01)00884838099241(21)224 (01)00884838099227(21)56 (01)00884838099241(21)287 (01)00884838099241(21)114 (01)00884838099258(21)67 (01)00884838099241(21)239 (01)00884838099241(21)249 (01)00884838099241(21)141 (01)00884838099258(21)783 (01)00884838099258(21)531 (01)00884838099227(21)28 (01)00884838099241(21)142 (01)00884838099241(21)235 (01)00884838099241(21)227 (01)00884838085268(21)703959 (01)00884838099258(21)600 (01)00884838099241(21)348 (01)00884838099241(21)176 (01)00884838099258(21)634 (01)00884838099241(21)321 (01)00884838099241(21)123 (01)00884838099227(21)32 (01)00884838099227(21)72 (01)00884838099203(21)8 (01)00884838099227(21)64 (01)00884838099234(21)46 (01)00884838099241(21)91 (01)00884838099227(21)2 (01)00884838099265(21)4 (01)00884838099241(21)95 (01)00884838099241(21)283 (01)00884838099234(21)21 (01)00884838099234(21)22 (01)00884838099241(21)295 (01)00884838099272(21)140 (01)00884838099227(21)5 (01)00884838099227(21)6 (01)00884838099227(21)7 (01)00884838099227(21)74 (01)00884838099241(21)218 (01)00884838099265(21)38 (01)00884838099227(21)40 (01)00884838099227(21)15 (01)00884838099272(21)166 (01)00884838099227(21)47 (01)00884838099227(21)48 (01)00884838099227(21)13 (01)00884838099241(21)140 (01)00884838099241(21)9 (01)00884838099241(21)49 (01)00884838099241(21)20 (01)00884838099241(21)157 (01)00884838099258(21)597 (01)00884838099258(21)810 (01)00884838099272(21)171 (01)00884838099258(21)413 (01)00884838099241(21)76 (01)00884838085268(21)304 (01)00884838099203(21)48 (01)00884838099210(21)27 (01)00884838099258(21)270 (01)00884838099227(21)52 (01)00884838099258(21)416 (01)00884838099203(21)45 (01)00884838099241(21)291 (01)00884838099258(21)535 (01)00884838099272(21)86 (01)00884838099258(21)576 (01)00884838099258(21)345 (01)00884838099258(21)198 (01)00884838099258(21)126 (01)00884838099258(21)457 (01)00884838099258(21)117 (01)00884838099258(21)241 (01)00884838099258(21)510 (01)00884838099241(21)86 (01)00884838099265(21)60 (01)00884838099265(21)76 (01)00884838099258(21)168 (01)00884838099272(21)157 (01)00884838099258(21)137 (01)00884838085268(21)893 (01)00884838099258(21)473 (01)00884838099265(21)77 (01)00884838099265(21)20 (01)00884838099258(21)397 (01)00884838099272(21)73 (01)00884838099241(21)107 (01)00884838099258(21)392 (01)00884838099234(21)30 (01)00884838099272(21)137 (01)00884838099203(21)11 (01)00884838099265(21)67 (01)00884838099272(21)210 (01)00884838099265(21)64 (01)00884838099272(21)77 (01)00884838099258(21)142 (01)00884838099265(21)80 (01)00884838099241(21)166 (01)00884838099265(21)70 (01)00884838099272(21)28 (01)00884838099265(21)75 (01)00884838099272(21)192 (01)00884838099272(21)193 (01)00884838099234(21)27 (01)00884838099265(21)57 (01)00884838099258(21)692 (01)00884838099272(21)110 (01)00884838099265(21)34 (01)00884838099272(21)91 (01)00884838099241(21)200 (01)00884838099272(21)43 (01)00884838099272(21)161 (01)00884838099265(21)69 (01)00884838099265(21)61 (01)00884838099265(21)63 (01)00884838099258(21)157 (01)00884838099241(21)184 (01)00884838099265(21)13 (01)00884838099272(21)46 (01)00884838099265(21)59 (01)00884838099265(21)117 (01)00884838099258(21)197 (01)00884838099265(21)58 (01)00884838099265(21)18 (01)00884838099265(21)92 (01)00884838099258(21)144 (01)00884838099258(21)212 (01)00884838099265(21)42 (01)00884838099272(21)283 (01)00884838099241(21)82 (01)00884838085268(21)703810 (01)00884838099258(21)375 (01)00884838099241(21)170 (01)00884838099241(21)4 (01)00884838099272(21)118 (01)00884838099241(21)1534 (01)00884838099241(21)118 (01)00884838099258(21)358 (01)00884838099258(21)508 (01)00884838099258(21)499 (01)00884838099258(21)530 (01)00884838099272(21)203 (01)00884838099210(21)37 (01)00884838099258(21)549 (01)00884838099203(21)15 (01)00884838099258(21)348 (01)00884838085268(21)703461 (01)00884838099241(21)263 (01)00884838099241(21)263 (01)00884838099241(21)159 (01)00884838099241(21)160 (01)00884838099258(21)211 (01)00884838099258(21)474 (01)00884838099227(21)35 (01)00884838099241(21)309 (01)00884838099241(21)315 (01)00884838099241(21)110 (01)00884838099258(21)243 (01)00884838099258(21)610 (01)00884838099258(21)542 (01)00884838099241(21)305 (01)00884838099272(21)233 (01)00884838099272(21)88 (01)00884838099258(21)203 (01)00884838099258(21)604 (01)00884838099241(21)179 (01)00884838099210(21)73 (01)00884838099258(21)698 (01)00884838099258(21)703 (01)00884838099258(21)743 (01)00884838099234(21)65 (01)00884838099241(21)276 (01)00884838099210(21)87 (01)00884838099258(21)751 (01)00884838099272(21)276 (01)00884838099258(21)705 (01)00884838099258(21)701 (01)00884838099265(21)8 (01)00884838099272(21)21 (01)00884838099258(21)537 (01)00884838099258(21)779 (01)00884838099258(21)629 (01)00884838099258(21)631 (01)00884838099272(21)168 (01)00884838099258(21)423 (01)00884838099258(21)456 (01)00884838099258(21)302 (01)00884838099258(21)305 (01)00884838099258(21)310 (01)00884838099241(21)264 (01)00884838099258(21)249 (01)00884838099258(21)386 (01)00884838099258(21)506 (01)00884838099258(21)259 (01)00884838099258(21)248 (01)00884838099203(21)42 (01)00884838099241(21)302 (01)00884838099227(21)8 (01)00884838099227(21)9 (01)00884838099265(21)31 (01)00884838099265(21)87 (01)00884838099272(21)207 (01)00884838099265(21)140 (01)00884838099258(21)551 (01)00884838099203(21)23 (01)00884838099203(21)26 (01)00884838099272(21)178 (01)00884838099272(21)179 (01)00884838099241(21)115; Serial Numbers: 839 131 577 81 271 879 1783 1447 282 512 360 370 584 239 425 232 591 580 39 198 589 362 954 10 214 183 526 441 121 80 326 518 404 252 453 472 465 129 174 553 517 400 342 582 196 1391 485 262 277 120 703826 38 36 139 1199 940 945 947 703680 964 703724 703541 703815 991 1013 943 1025 417 511 559 560 340 45 703560 810 272 256 364 164 1250 226 860 1105 464 703523 703524 1418 1209 1427 703537 703538 703517 1426 395 139 1003 207 209 211 447 232 412 1547 59 92 1005 220 799 221 62 201 185 145 257 352 353 141 368 132 165 117 195 555 267 268 271 270 255 224 56 287 114 67 239 249 141 783 531 28 142 235 227 703959 600 348 176 634 321 123 32 72 8 64 46 91 2 4 95 283 21 22 295 140 5 6 7 74 218 38 40 15 166 47 48 13 140 9 49 20 157 597 810 171 413 76 304 48 27 270 52 416 45 291 535 86 576 345 198 126 457 117 241 510 86 60 76 168 157 137 893 473 77 20 397 73 107 392 30 137 11 67 210 64 77 142 80 166 70 28 75 192 193 27 57 692 110 34 91 200 43 161 69 61 63 157 184 13 46 59 117 197 58 18 92 144 212 42 283 82 703810 375 170 4 118 1534 118 358 508 499 530 203 37 549 15 348 703461 263 263 159 160 211 474 35 309 315 110 243 610 542 305 233 88 203 604 179 73 698 703 743 65 276 87 751 276 705 701 8 21 537 779 629 631 168 423 456 302 305 310 264 249 386 506 259 248 42 302 8 9 31 87 207 140 551 23 26 178 179 115

Quantity Affected: 338

Reason for Recall

Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from a different patient.

Distribution

Global Distribution. US Nationwide.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-02-02

Company

Philips North America Llc

Cambridge, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Philips North America Llc has 302 FDA actions in our database, including 302 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Philips North America Llc have FDA actions?

Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0874-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

Want to know the moment something like this happens?

Get alerts for device

Related Actions

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200

Covidien LP · 2023-08-23

Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO

MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15

VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri

Boston Scientific Corporation · 2024-09-25

EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo

Enchroma Inc · 2024-11-27

Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;

Adept Medical Ltd · 2025-01-29