Siemens Axiom Artis zeego Angiographic X-Ray System Recall
Siemens is recalling 52 Axiom Artis zeego systems due to a potential risk to patients or operators during operation.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where specific injuries or illnesses have not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 52 Siemens Axiom Artis zeego angiographic x-ray systems. The affected units are equipped with software versions VC14, VC20, or VC21 and a specific technical configuration that cannot be completely executed.
The recall was initiated after the firm's product monitoring activities identified a potential risk to patients or operators during the operation of these systems. The agency has classified this recall as Class II.
The affected systems were distributed nationwide, including in Alabama, Arkansas, Arizona, California, Connecticut, the District of Columbia, Florida, Georgia, Iowa, Illinois, Louisiana, Maryland, Michigan, Missouri, North Carolina, New Hampshire, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Washington, Wisconsin, and Puerto Rico. Specific serial numbers for the affected units are listed in the official recall notice.
The recalled product
- Product
- Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 52
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)
- Model number 10280959 -- serial numbers 160395
- 160484
- 190348
- 160502
- 160351
- 160463
- 160823
- 160406
- 160347
- 160506
- 160142
- 160801
- 160486
- 160431
- 160100
- 160814
- 160391
- 160008
- 160411
- 160438
Distribution
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