Philips Recalls Two Azurion FlexArm Units Due to Cable Damage
Philips is recalling two Azurion FlexArm units because a manufacturing error caused damage to the 24V power cable of the detector.
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, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Philips North America, LLC is recalling two units of the Azurion FlexArm, model 722079. The recall affects serial numbers 637 and 638. These units were distributed to one account in Florida and one international account in Germany.
The recall was initiated because, during the manufacturing of an Azurion R2.0 system, it was discovered that the cable set did not meet specifications. This manufacturing error resulted in damage to the 24V power cable of the detector.
No specific instructions for consumers are provided in the source text, but the affected units are limited to the two specific serial numbers listed.
The recalled product
- Product
- Azurion FlexArm, 722079
- Manufacturer
- Philips North America, LLC
- Hazard
- Affected units
- 2
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 (2)
- Serial numbers 637
- 638
Distribution
Distributed in 1 state:
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