Philips ProxiDiagnost N90 Medical Device Recalled for Radiation Dose Increase
Philips North America, LLC is recalling 71 ProxiDiagnost N90 systems in the United States because an unexpected increase in peak tube potential may lead to increased patient radiation dose.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the potential for significant harm from increased radiation exposure.
Plain-English summary
Philips North America, LLC is recalling 71 units of the ProxiDiagnost N90 medical device in the United States. The recall is due to a defect that causes an unexpected increase in peak tube potential (kV), which leads to an increased patient radiation dose.
All ProxiDiagnost N90 systems are affected by this issue. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers and healthcare facilities should contact the recalling firm for further instructions on how to proceed with the affected devices.
The recalled product
- Product
- ProxiDiagnost N90
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 71
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)
- All ProxiDiagnost N90 systems are affected.
Distribution
Distribution scope not specified by the agency.
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