Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
This recall has been terminated (originally issued April 24, 2014).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- March 17, 2014
- Posted
- April 24, 2014
- Terminated
- September 16, 2020
- Recall Number
- Z-1503-2014
- Quantity
- 985 devices
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The footboard of Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held.
Distribution
Nationwide: US: AL, AR, AZ, CA, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WY / Worldwide including Canada & Mexico
Lot / Code Info
Units distributed from November 2006 through March 2014.
Root Cause
Process control
Action Taken
On March 17, 2014, consignees were notified of the recall via letter. The letter explains what the issue is, actions firms can take to avoid or minimize the occurrence of the issue, and the actions planned by Philips to correct the issue. For further information or support concerning this issue, please contact your local Philips Representative. 1-800-722-9377