Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT s
Summary
The FDA issued a Class II for Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Brack by Philips North America Llc. Reason: Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Su.
Details
Source
Device Recall
External ID
Z-1981-2021
Action Date
2021-07-07
Status
Ongoing
Category
device
Product Description
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace
Lot/Code Info: Model/ Serial Number/UDI: N/A 728240 60005 728240 60003 728240 6017 728240 60012 728240 60007 728240 6105 728240 6136 728240 60016 728240 60014 728240 60006 728240 6156 728240 5080 728240 60011 728240 6109 728240 5413 728245 3371 728245 3394 728245 3484_ 728245 3500 728245 3377 728245 . 728245 3448 728245 3483 728245 3443 728245 3360 728245 9732 728245 3426 728245 3429 728245 6109 728245 3408 728245 3473 728245 3419 728246 260032 728246 6444 728246 6265 728246 5452 728246 40018 728246 6618 728246 50081 728246 50014 728246 50026 728246 6556 728246 5449 728246 50029 728246 5485 728246 5942 728246 50046 728246 30019 728246 5313 728246 5013 728246 50096 728246 5207 728246 5916 728246 50094 728246 30033 728246 50032 728246 5174 728246 6503 728246 6519 728246 6511 728246 5773 728246 5816 728246 260015 728246 6491 728246 5296 728246 50188 728246 30103 728246 5041 728246 4017 728246 5632 728246 50010 728246 5658 728246 3382 728246 30063 728246 5515 728246 5343 728246 50053 728246 5621 728246 6141 728246 50209 728246 5431 728246 9374 728246 50005 728246 6632 728246 50025 728246 30109 728246 5754 728246 50211 728246 5078 728246 3170 728246 6255 728246 3014 728246 5097 728246 6612 728246 5812 728246 60013 728246 6533 728246 50134 728255 9802 728255 9728 728255 9795 728256 3382 728256 30103 728256 30100 728256 3014 728256 3296 728256 3463 728256 3344 728256 30029 728256 3113 728256 3063 728256 30110 728256 30063 728266 3635 728250 2579 728251 40008 728251 40004 728251 40006 728251 4005 728251 3008 728251 40021 728251 40019 728260 7330 N/A 728260 12323 N/A
Quantity Affected: 1,301 Monitor Bracket Assemblies total
Reason for Recall
Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, AE, AR, AT, AU, BD, BE, BR, CH, CL, CN, CO, CU, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GE, GI, GL, GR, HK, HU, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KE, KG, KH, KR, LA, LB, LK, LT, LY, MM, MN, MU, MV, MY, NI, NL, NO, NZ, OM, PA, PF, PH, PK, PL, PS, PT, QA, RE, RU, RW, SA, SE, SG , SI, SK, TH, TN, TR, UZ, VN, XK, YE, ZA, ZW.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-01
Company
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 52 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-1981-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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