FDA Medical Device Recalls (openFDA)
Ziehm Imaging Inc: Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
- Recall number
- Z-1893-2017
- Recalling firm
- Ziehm Imaging Inc
- Product
- Ziehm Imaging solo FD Mobile Fluoroscopic C-arm
- Status
- Terminated
- Initiated
- 2017-02-23
- Posted
- not on file
- Terminated
- 2019-12-11
- Reason
- During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component
- Root cause
- Labeling design
- Action
- Ziehm Imaging will bring defect into compliance: Customer Precautions: Therefore, as there is no identifiable risk to patients, users or third parties, the manufacturer Ziehm Imaging GmbH advises customers they may continue to operate the affected device until the labeling materials can be remediated. Please alert all staff members working with the device to this notification. Remedy: 1. You will contact customers and initiate the actions to correct the failure to comply issues. 2. You will affix the identification labels to the collimator and x-ray control panel. 3. You will replace the existing user manual with one that reflects the reference images of the labels with manufacturer date. If there are any questions or concerns regarding this product safety issue, please do not hesitate to contact our National Service Team for further information at Ziehm Imaging, Inc. Toll-Free: (866) 949-4346, Fax: (866) 839-7893 or E- Mail: customerservice@ziehm.com
- Quantity
- US - 2 systems
- Distribution
- US Distribution to the states of : FL and CA. No devices listed in this recall where distributed any foreign /military/government consignees from the U.S.A.
- Lot, serial or model codes
- S/N 52199, 52108
- 510(k) numbers
- ["K161976"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 2027299
- Firm city
- Orlando
- Firm state
- FL
- 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