Philips Healthcare Recalls Mobile X-ray Systems Due to Unintended Radiation
Philips Healthcare is recalling 11 mobile X-ray systems because they may generate unintended radiation pulses when switched off or parked.
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 3/5 (High).
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 involves a medical device with a risk of unintended radiation exposure. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and it is not classified as FDA Class I.
Plain-English summary
Philips Healthcare Inc. is recalling 11 units of the Practix Convenio Mobile X-ray system. The recall is due to a defect where the system may inadvertently generate a radiation pulse (50 kV, 2.5 pGy) when the system is switched off or when the tube arm is parked in the down position with the X-ray generator switch off.
The source text indicates the failure is related to a component supply issue. The recall covers units distributed nationwide in the United States. No specific dates, lot numbers, or reports of injury are provided in the source text.
Consumers and healthcare facilities with these devices should contact Philips Healthcare for instructions on how to address the defect. The source does not specify a particular action for end-users beyond the recall notification.
The recalled product
- Product
- Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
- Manufacturer
- Philips Healthcare Inc.
- Hazard
- Affected units
- 11
Distribution
Distributed nationwide across the United States.
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