FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
- Recall number
- Z-0364-2016
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
- Status
- Terminated
- Initiated
- 2014-08-19
- Posted
- not on file
- Terminated
- 2016-06-14
- Reason
- The hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
- Root cause
- Device Design
- Action
- The Field Safety Notice FCO70600086 will be mailed on August 19, 2014. Philips Medical Systems will send out certified letters and will have the receipts returned for tracking purposes as well as have a Field Service Engineer visit each site to provide the fix when the Field Change Order is released.
- Quantity
- 1517 systems, not all units have the patient support accessory
- Distribution
- Distributed in the states of MN, KY, MA, VA, TX, NC, HI, FL, AZ, CT, and WY and the countries of Argentina, Australia, Austria, Canada, Denmark, Germany, Netherlands, Russia, Saudi Arabia, Singapore, Spain, and Switzerland.
- Lot, serial or model codes
- All patient support for stitching are affected.
- 510(k) numbers
- ["K945278"]
- PMA numbers
- not on file
- Product code
- KPR
- 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