FDA Medical Device Recalls (openFDA)
Philips Healthcare Inc.: Mobile Diagnostic X-Ray System with Digital Panel
- Recall number
- Z-1706-2017
- Recalling firm
- Philips Healthcare Inc.
- Product
- Mobile Diagnostic X-Ray System with Digital Panel
- Status
- Terminated
- Initiated
- 2012-11-28
- Posted
- not on file
- Terminated
- 2018-05-31
- Reason
- When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.
- Root cause
- Software design
- Action
- Philips Medicals Systems distributed an "URGENT Field Safety Notice" alerting customers of the defect on November 28, 2012. Customers are requested to manually rotate images by using the rotation tool.Customers are also recommended to check whether the automatic marker is set correctly, especially after a manual image rotation is performed. The marker can be corrected manually with the annotation tool.
- Quantity
- 220 systems
- Distribution
- Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
- Lot, serial or model codes
- *** All units ***
- 510(k) numbers
- ["K111725"]
- PMA numbers
- not on file
- Product code
- IZL
- 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