Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2019 - (Recall #: Z-0214-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.

Product Classification:

Class I

Date Initiated: September 19, 2019

Date Posted: November 13, 2019

Recall Number: Z-0214-2020

Event ID: 84009

Reason for Recall:

An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

Status: Terminated

Product Quantity: 1167 in total

Code Information:

System Code: 882290 and 882291 All systems.

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated