Philips Healthcare Recalls UNIQ Systems Due to Shutter Position Reset Issue
Philips Healthcare is recalling 459 UNIQ systems because the shutter position resets to open when a new procedure type is selected, potentially losing previous settings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a software configuration issue without reporting any injuries, illnesses, or hospitalizations. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Philips Healthcare is recalling 459 UNIQ systems distributed nationwide in the United States. The affected software versions are UNIQ 1.0.10 and UNIQ 1.0.10.5. These systems are used for vascular, cardiovascular, and neurovascular imaging applications, including diagnostic, interventional, and minimally invasive procedures.
The recall is due to a software issue where the shutter position resets to the open position the first time an operator selects a new procedure type during a single examination. If the shutters had been previously adjusted during the examination, that specific setting is not retained after the procedure type is changed. This behavior may affect the intended imaging configuration for the new procedure type.
Healthcare facilities using these systems should contact Philips Healthcare for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as…
- Manufacturer
- Philips Healthcare
- Category
- Medical Device — Imaging Systems
- Affected units
- 459
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 1.0.10 UNIQ 1.0.10.5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Philips Healthcare 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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