Reported Nov 8, 2023 · Ongoing
***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes
- Material Number11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of patients during
- clinical applications Material Number10308194
- Lot codes and dates
- ***Updated 12/4/23*** (1)
- UDI-DI04056869246628
- S/N2)
186 of 186 codes
800068000980010800148001780018800198002080021800228002380025800268002880031800328003380048800518005280053800558005980060800638006480065800678006880069800718007280073800748007580080800818201082011820128201382028820318203682037820388203982040820438204482045820468206182075820768207982080820898209282095
- UDI-DI04056869153506
- Serial
181 of 181 codes
500305003250033500485005050051500725007350075500795008150088500945009650098501015010750109501115012050122501235012450127501295013050131501325013550153501555016650171501845018550192501985019950200502015020950210502115021350214502155021650219502225027650282503025031150315504265042750429504315044452008
- Amount recalled
- ***Updated 12/4/23*** 186 units Cios Flow, 181 units Cios Spin
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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