CLASS II Device recall · Reported 20 Nov 2013 · FDA Enforcement Report
Artis zee systems x-ray, angiographic system recalled
Siemens Medical Solutions USA is recalling Artis zee systems x-ray, angiographic system, distributed in 14 states. The recall was initiated on 21 Jan 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0172-2014
- FDA event ID
- 65795
- Recalling firm
- Siemens Medical Solutions USA, Malvern, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2013
- FDA classified
- 14 Nov 2013
- Reported
- 20 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 21 Jan 2013 | Recall initiated by company | |
| 14 Nov 2013 | Classified by FDA | +297 days |
| 20 Nov 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
Product as listed by the FDA
Artis zee systems x-ray, angiographic system
Where it was distributed
US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
ArkansasArizonaCaliforniaConnecticutFloridaIowaKansasKentuckyMissouriMontanaNew YorkOklahomaPennsylvaniaWest Virginia
Questions about this recall
Why was it recalled?
The firm became aware of a potential issue with Artis zee systems bearing model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot where a dislocation of the scatter radiation filter inside the card collimator may occur.
Which lots are affected?
model numbers 10094135, 10094137, and 10094141 equipped with a card collimator from a specific lot
Where was it sold?
US Distribution including the states of AZ, KY, PA, IA WV, FL, MO, OK, CA, AR, MT, NY, KS, and CT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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