Philips Recalls UNIQ 1.0 Fluoroscopy Systems Due to Power Supply Failures
Philips is recalling 1,536 UNIQ 1.0 fluoroscopy systems because certain low-voltage DC power supplies have an increased failure rate.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The increased failure rate of power supplies in medical imaging equipment poses a risk of harm if the device malfunctions during a procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Electronics North America Corporation is recalling 1,536 UNIQ 1.0 fluoroscopy systems, including various UNIQ FD10, FD20, and OR Table models. The recall is due to an increase in the failure rate of certain low-voltage DC power supplies (DCPS) used in these devices.
The affected devices were distributed nationwide in the United States and in numerous international locations, including Canada, Australia, and various countries in Europe, Asia, and the Americas. The specific models involved include the UNIQ FD10, UNIQ FD10/10, UNIQ FD20, UNIQ FD20/10 biplane, and their corresponding OR Table variants, all with release R1.0.
Healthcare facilities should contact Philips for instructions on how to address the power supply issue. The source text does not specify the exact remediation steps, such as whether the power supplies will be replaced or if the devices will be repaired.
The recalled product
- 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
- Manufacturer
- Philips Electronics North America Corporation
- Hazard
- Affected units
- 1,536
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UNIQ with release R1.0
Distribution
Part of a larger recall action
This product is one of 2 recalled by Philips Electronics North America Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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