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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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 Class 2 Device Recall Philipssee related information
Date Initiated by FirmJuly 07, 2016
Create DateAugust 26, 2016
Recall Status1 Terminated 3 on July 14, 2020
Recall NumberZ-2670-2016
Recall Event ID 74616
510(K)NumberK141979 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductUNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058; UNIQ FD20/15 OR Table 722059
Code Information UNIQ with release R1.0
FEI Number 1218950
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-659-3000
Manufacturer Reason
for Recall		Increase in the failure rate of certain low-voltage DC power supplies (DCPS)
FDA Determined
Cause 2		Component change control
ActionPhilips sent an Urgent - Field Safety Notice dated June 20, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips Field Service Engineers will replace the affected DCPS free of charge. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377. For further questions regarding this recall please call (978) 659-3000.
Quantity in Commerce1536 devices (includes both Allura and UNIQ)
DistributionNationwide, Canada, Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Bulgaria CHILE China Colombia Croatia Cuba Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt Finland France French Polynesia Georgia Germany Greece Honduras Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Lebanon Lithuania Macedonia Malaysia Malta Mexico Morocco Myanmar Nepal Netherlands New Caledonia Norway Oman Pakistan Palestine, State of PERU Philippines Poland Portugal Qatar R¿union Romania RUSSIAN FEDERAT Russian Federation Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Tanzania Thailand Tunisia Turkey Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
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