Philips Azurion 7 M20 X-Ray System Recalled for Loose Screw Risk
Philips is recalling 162 Azurion 7 M20 angiographic X-ray systems because unspecified torque on C-arm roll motor screws could cause them to become loose.
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 is classified as FDA Class II, and the hazard involves a mechanical defect in a medical device that could lead to injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips North America, LLC is recalling 162 units of the Phillips Azurion 7 M20 Angiographic X-Ray System (Code 722079). The recall is due to a defect where no torque was specified for the four screws that connect the gearbox and the mounting flange within the C-arm roll motor. This lack of specification could result in the screws becoming loose.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous international countries. The systems are used for image guidance in diagnostic, interventional, and minimally invasive surgery procedures for vascular, non-vascular, cardiovascular, and neuro applications.
Hospitals and healthcare facilities should check their inventory for the specific serial numbers and system equipment numbers listed in the official recall notice. Affected units should be removed from service and contacted with the manufacturer for further instructions.
The recalled product
- Product
- Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
- Manufacturer
- Philips North America, LLC
- Affected units
- 162
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 (20)
- Serial Numbers: 709
- 710
- 711
- 713
- 716
- 715
- 439
- 526
- 637
- 653
- 684
- 621
- 497
- 792
- 595
- 674
- 737
- 628
- 429
- 605
Distribution
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