Philips Azurion 7 M20 FlexArm system recalled for software connectivity loss
Philips Medical Systems recalls the Azurion 7 M20 FlexArm system due to a software issue causing loss of connectivity between the FlexArm and Maquet Magnus Table. The recall affects 28 systems worldwide.
What this means for you
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: This is an FDA Class II recall of a medical device with no reported illnesses or injuries. The hazard—loss of connectivity in a surgical imaging system—poses a potential risk of harm by impairing device function during use, meeting the criterion for a High severity rating.
Plain-English summary
Philips Medical Systems Nederland is recalling the Azurion 7 M20 FlexArm system (software version R2.x) with Maquet Magnus Table (software version 05.02.12) due to a software issue causing loss of connectivity between the two components.
The FlexArm and Table communicate via software to coordinate imaging and procedural functions. When connectivity is lost, the system cannot function as intended, which could impair the surgeon's ability to operate the imaging system during procedures.
This recall affects 28 systems globally: 9 in the United States (Colorado, Florida, Illinois, Mississippi, Nevada, and Texas), 1 in Canada, and 18 in other countries.
Facilities using affected systems should contact Philips Medical Systems Nederland immediately for technical assistance and guidance on remediation or replacement options.
The recalled product
- Product
- Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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)
- (1) System Code: 722079
- (1) UDI/DI: 00884838085268
- (1) Serial Number: 1086
- 1392
- 703615
- 1079
- 743
- 703456
- 1248
- (2) System Code: 722224
- (2) UDI/DI: 00884838099258
- (2) Serial Number: 1337
- 1249
- 1925
- 1250
- 468
- 379
- 647
- 633
- 1534
Distribution
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