FDA Medical Device Recalls (openFDA)
Philips Medical Systems, Inc.: Philips Healthcare DigitalDiagnost System X-Ray
- Recall number
- Z-1554-2015
- Recalling firm
- Philips Medical Systems, Inc.
- Product
- Philips Healthcare DigitalDiagnost System X-Ray
- Status
- Terminated
- Initiated
- 2015-02-09
- Posted
- 2015-05-19
- Terminated
- 2016-06-14
- Reason
- The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j).
- Root cause
- Software design (manufacturing process)
- Action
- Philips Healthcare Planned action: 1. Philips healthcare will contact customers and initiate a software update to correct the software deficiency causing the problem. 2. Philips engineers will install the software. 3. Philips engineers will perform testing to ensure the software update was effective. 4. Corrections are to be made free of charge 5. Corrective actions should be completed by August 15, 2015 For further questions call (978) 659-7892
- Quantity
- 54 DigitalDiagnost
- Distribution
- Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and United Kingdom.
- Lot, serial or model codes
- Digital Diagnost Stationary X-ray System Release 4.0.0, 4.0.1, 4.0.2
- 510(k) numbers
- ["K141736"]
- 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