FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system
- Recall number
- Z-3009-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Axiom Artis U mobile x-ray system Product Usage: Mobile x-ray system
- Status
- Terminated
- Initiated
- 2011-06-29
- Posted
- 2011-08-11
- Terminated
- 2014-01-24
- Reason
- When the heat unit of the angiography system reaches or exceeds 65%, the cool down time display will appear with an acoustic signal. If users ignore the warning and continue the radiation, the tube may be autoprotected when it reaches its temperature limitation causing the X-Ray to lock until the tube cools down. Following a tube auto-protection, an error message "Door is Open" or "Err 421/240:
- Root cause
- Labeling False and Misleading
- Action
- Siemens sent a "Customer Safety Advisory Notice" letters to all affected users dated June 13, 2011. The letter identified the product, the problem, and the actions to be taken. Siemens included in the notice an addendum to the instruction for use to each system and request customers to take special attention. Customers were instructed to place the Safety Notice in the System's instruction for use. All appropriate personnel should be notified of the correction notice. If product was distributed further, customers were to forward the safety notice to the new owner and inform the firm of the new owner.
- Quantity
- 18
- Distribution
- Nationwide Distribution (USA) including the states of: CA, CT, FL, KS, MN, MO, NJ, NY, NC, PA, and UT.
- Lot, serial or model codes
- Model number 10094012; serial numbers 20202, 20223, 20231, 20422, 20402, 20435, 21022, 22002, 21005, and 20432. Model number 7008530; serial numbers 20146, 21112, 20003, 20115, 20135, 20006, 20113, and 20120.
- 510(k) numbers
- ["K040675"]
- PMA numbers
- not on file
- Product code
- IZL
- 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
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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