Skip to content
Recall Observatory FDA recall evidence

Device product

Digital Diagnost, stationary radiographic system; Models: 712020/22/25/26/50/52/54/55/57/60/62/80/81/82/85

Z-1503-2014

March 17, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 67859
Status
Terminated
Classification
Class II
Quantity
985 devices
Official record key
device-enforcement:Z-1503-2014

Official wording

Reason: 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.

Code information: Units distributed from November 2006 through March 2014.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.