FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
- Recall number
- Z-0301-2022
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
- Status
- Terminated
- Initiated
- 2021-10-20
- Posted
- not on file
- Terminated
- 2024-06-18
- Reason
- If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure
- Root cause
- Software design
- Action
- Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice dated 10/202/1 to customers via AX070/21/S, Siemens will update the system software via Update Instruction AX069/21/S. Letter states reason for recall, health risk and action to take: To avoid the problem, it is recommended to position the SID first and then release x-ray. Siemens will correct the software error (software VD12) via Update Instruction AX069/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. We do not consider it necessary to re-examine any patients in relation to the issues described above. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
- Quantity
- 67 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Serial Numbers: 110088 110059 110103 110035 110046 110005 110058 110056 110062 109523 109645 110067 110095 110051 110001 110020 110007 110093 110069 110075 109627 110042 110043 110048 110061 110063 110064 110032 110047 110102 110039 110040 110023 110065 110052 110018 110072 110081 110036 110054 110053 110044 110031 110016 110037 110077 109497 110079 110099 110027 110049 110066 110024 110017 110025 110100 110083 110091 110006 110055 110026 110022 110000 133501 110057 110104 110041 Expanded Recall 11/15/21: 110096 110014
- 510(k) numbers
- ["K181407"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28