Philips Electronics North America Corporation: Medical Device Recall in 2016 - (Recall #: Z-2682-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Philips DuraDiagnost stationary X-ray system

Product Classification:

Class II

Date Initiated: September 17, 2015

Date Posted: September 7, 2016

Recall Number: Z-2682-2016

Event ID: 74685

Reason for Recall:

Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].

Status: Terminated

Product Quantity: 15

Code Information:

SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093

Distribution Pattern:

US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.

Voluntary or Mandated:

FDA Mandated