Recalls / —
—#154245
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
- FDA product code
- OWB — Interventional Fluoroscopic X-Ray System
- Device class
- Class 2
- Medical specialty
- Radiology
- Affected lot / code info
- Devices with a Laird Chiller.
Why it was recalled
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 (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Philips Electronics North America Corporation
- Address
- 3000 Minuteman Rd, Andover, Massachusetts 01810-1032
Distribution
- Distribution pattern
- Nationwide, worldwide including Canada
Timeline
- Recall initiated
- 2017-03-22
- Terminated
- 2021-05-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #154245. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.