FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
- Recall number
- Z-0475-2013
- Recalling firm
- Philips Healthcare Inc.
- Product
- Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
- Status
- Terminated
- Initiated
- 2012-10-30
- Posted
- 2012-12-05
- Terminated
- 2017-01-17
- Reason
- With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a circle" appears in the lower left corner. This can be mistaken for a "Right patient side" marker, although this can appear on the left patient side.
- Root cause
- Software design
- Action
- Philips Healthcare initiated a recall on October 25, 2012 via Urgent - Field Safety Notice for the Digital Diagnost X-ray System. The letter identified the affected product, problem and actions to be taken. The letter informs customers that Philips will supply a software update kit to version 2.1.4. For questions please contact your local Philips representative 1-800-722-9377.
- Quantity
- 623 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, India, Indonesia, Iraq, Italy, Japan, Latvia, Lithuania, Libya, Malta, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
- Lot, serial or model codes
- All Digital Diagnost systems with release 2.0.2 and 2.0.2 SP1 Models 712020, 712022
- 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