FDA Medical Device Recalls (openFDA)
Philips Electronics North America Corporation: Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
- Recall number
- Z-0766-2016
- Recalling firm
- Philips Electronics North America Corporation
- Product
- Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
- Status
- Terminated
- Initiated
- 2015-07-22
- Posted
- not on file
- Terminated
- 2020-10-14
- Reason
- If arm is not fastened securely it could fall down.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were notified of the recall via letter sent certified return receipt on 7/22/2015. The letter informs customers that the Instruction for Use (IFU) requires the operator not to use the system and call for service, if a mechanical defect or malfunction is suspected. In this case, it is recommended not to position the Ceiling suspension with the Trauma arm directly above a patient as long as this Field Change Order is not yet installed. Philips plans to repair the affected systems. A Philips Service Engineer will contact customers as soon as the Field Action Kit is ready to be implemented. For questions, contact your local representative or use the Technical Support Line at 1-800-722-9377. When communicating with Philips regarding this issue, please reference Field Change Order 72000014.
- Quantity
- 399 distributed, 262 are subject to this event
- Distribution
- Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.
- Lot, serial or model codes
- All TraumaDiagnost products that were delivered before the week of July 2, 2007.
- 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