FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
- Recall number
- Z-1503-2014
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
- Status
- Terminated
- Initiated
- 2014-03-17
- Posted
- 2014-04-24
- Terminated
- 2020-09-16
- Reason
- The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
- Root cause
- Process control
- Action
- On March 17, 2014, consignees were notified of the recall via letter. The letter explains what the issue is, actions firms can take to avoid or minimize the occurrence of the issue, and the actions planned by Philips to correct the issue. For further information or support concerning this issue, please contact your local Philips Representative. 1-800-722-9377
- Quantity
- 985 devices
- Distribution
- Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico
- Lot, serial or model codes
- Units distributed from November 2006 through March 2014.
- 510(k) numbers
- ["K982795"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- 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