Philips Centron Medical Imaging Systems Recalled for Shutter Reset Issue
Philips Healthcare is recalling 459 Centron systems because shutter settings reset when procedure types change, potentially affecting imaging accuracy.
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 does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score involving low-risk software defects without reported harm.
Plain-English summary
Philips Healthcare is recalling 459 Centron medical imaging systems distributed nationwide in the United States. The affected software versions are Centron 1.0.10, 1.0.10.1, and 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 defect where the shutter position resets to the open position when an operator selects a new procedure type during a single examination. If the shutters had been manually adjusted previously, that setting is not retained after the first procedure type change. This may result in unintended shutter positions during imaging.
Healthcare facilities using these systems should contact Philips Healthcare for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Centron 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)
- Centron 1.0.10 Centron 1.0.10.1 Centron 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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