Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85
FDA Recall Z-1503-2014 · Posted 2014-04-24
Advertisement
Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeMQB
Date Initiated2014-03-17
Date Terminated2020-09-16
Product Quantity985 devices
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.
Firm Action
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
Root Cause
Process control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement