FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
- Recall number
- Z-3190-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
- Status
- Terminated
- Initiated
- 2018-07-29
- Posted
- not on file
- Terminated
- 2019-05-17
- Reason
- Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
- Root cause
- Device Design
- Action
- Urgent Medical Device Correction notification letters dated 7/27/18 were distributed to customers. The letters informed the customers of the following planned actions: Our service organization will contact you shortly to arrange a date to perform this corrective action with Update Instruction AX001/18/S. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. Additionally, Siemens is developing a solution to restore the system back to the original settings. This solution will be distributed to all affected customers upon completion.
- Quantity
- 429 total
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- 164013 164011
- 510(k) numbers
- ["K163286"]
- 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