Z-2670-2016Class II

UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10...

Name: Z-2670-2016 UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10...
Creator: Philips Electronics North America Corporation
Published: 2016-07-07
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2016-07-07 / Terminated

FDA source

Philips Electronics North America Corporation began a recall of 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... on 2016-07-07. FDA classified it as Class II and gives the reason as "Increase in the failure rate of certain low-voltage DC power supplies (DCPS)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2670-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-07
Posted: 2016-08-26
Terminated: 2020-07-14
Recalling firm: Philips North America LLC
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
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Increase in the failure rate of certain low-voltage DC power supplies (DCPS)
FDA root cause: Component change control
Action: 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.
Quantity in commerce: 1536 devices (includes both Allura and UNIQ)
Distribution: 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
Product codes and lots: UNIQ with release R1.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2670-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2669-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26
Z-2670-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26

Product code OWB

K141979Class IIAllura Xper Fd Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV / cleared 2014-08-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)