System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 A
Summary
The FDA issued a Class II for System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 7220 by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dr.
Details
Source
Device Recall
External ID
Z-3166-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
Product Description
System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 722028 Allura Xper FD20 722027 Allura Xper FD10/10 722026 Allura Xper FD10 722025 Allura Xper FD20 Biplane OR Table 722023 Allura Xper FD20 OR Table 722020 Allura Xper FD20 Biplane OR Table 722015 Allura Xper FD20 OR Table 722013 Allura Xper FD20 Biplane 722012 Allura Xper FD20 722011 Allura Xper FD10/10 722010 Allura Xper FD10 722008 Allura Xper FD20 Biplane 722006 Allura Xper FD20 722005 Allura Xper FD10/10 722003 Allura Xper FD10 722002 Allura Xper FD10F 722001 Allura Xper FD10C
Lot/Code Info: Model Product UDI-DI: 722059 Allura Xper FD20/15 OR Table (01)00884838059122(21) 722058 Allura Xper FD20/15 (01)00884838059115(21) 722039 Allura Xper FD20/20 OR Table - 722038 Allura Xper FD20/20 (01)00884838054226(21) 722035 Allura Xper FD20 OR Table (01)00884838054240(21) 722029 Allura Xper FD20/10 (01)00884838054219(21) 722028 Allura Xper FD20 (01)00884838054202(21) 722027 Allura Xper FD10/10 (01)00884838054196(21) 722026 Allura Xper FD10 (01)00884838054189(21) 722025 Allura Xper FD20 Biplane OR Table - 722023 Allura Xper FD20 OR Table - 722020 Allura Xper FD20 Biplane OR Table - 722015 Allura Xper FD20 OR Table - 722013 Allura Xper FD20 Biplane (01)00884838059061(21) 722012 Allura Xper FD20 (01)00884838059054(21) 722011 Allura Xper FD10/10 - 722010 Allura Xper FD10 (01)00884838059030(21) 722008 Allura Xper FD20 Biplane - 722006 Allura Xper FD20 (01)00884838055513(21) 722005 Allura Xper FD10/10 (01)00884838080805(10) 722003 Allura Xper FD10 (01)00884838059191(10) 722002 Allura Xper FD10F - 722001 Allura Xper FD10C - All Serial Numbers
Quantity Affected: 9318 units
Reason for Recall
Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
Distribution
Nationwide, Canada and Worldwide: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Brazil Brunei Darussalam Bulgaria Cambodia Cayman Islands Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cuba Curacao Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Estonia Ethiopia Fiji Finland France French Polynesia Georgia Germany Ghana Gibraltar Greece Guadeloupe Guinea Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Libya Lithuania Macao Macedonia Malaysia Maldives Malta Martinique Mauritania Mauritius Mexico Mongolia Morocco Myanmar Nepal Netherlands New Caledonia New Zealand Nicaragua Norway Oman Pakistan Palestine, State of Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Qatar R¿union Romania Russian Federation Saudi Arabia Senegal Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sudan Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela Viet Nam Virgin Islands (U.S.) Yemen
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-22
Company
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 257 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
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 MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3166-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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