FDAClass IISeptember 25, 2024

System Name: 722059 Allura Xper FD20/15 OR Table 722058 recall

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…

Why was System Name: 722059 Allura Xper FD20/15 OR Table 722058 recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Quantity
9318 units
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
Recall date
September 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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