Z-1821-2017Class II

UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ...

Name: Z-1821-2017 UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ...
Creator: Philips Electronics North America Corporation
Published: 2017-03-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2017-03-22 / Terminated / root cause: packaging

FDA source

Philips Electronics North America Corporation began a recall of UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table... on 2017-03-22. FDA classified it as Class II and gives the reason as "Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1821-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-22
Posted: 2017-04-14
Terminated: 2021-05-17
Recalling firm: Philips North America LLC
Product: UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips.
Quantity in commerce: 6992 (total for all devices)
Distribution: Nationwide, worldwide including Canada
Product codes and lots: Devices with a Laird Chiller.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1821-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1820-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-14
Z-1821-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-14
Z-1822-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-14

Product code OWB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)