—#148175

Product

UNIQ 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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K141979
Affected lot / code info: UNIQ with release R1.0

Why it was recalled

Increase in the failure rate of certain low-voltage DC power supplies (DCPS)

Root cause (FDA determination)

Component change control

Action the firm took

Philips 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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Nationwide, 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

Timeline

Recall initiated: 2016-07-07
Terminated: 2020-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148175. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.