Recall Z-1598-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1598-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-13

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-03-13, terminated 2018-06-26. It names 2 FDA 510(k) clearances: K952684, K922080. Product: Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH. Reason: During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Terminated: 2018-06-26
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K952684 — VERTEX EPIC MCDAdac Laboratories·cleared 1995-11-24
K922080 — GENESYS IIAdac Laboratories·cleared 1992-07-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

Reason for recall

During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.

Data sourced from openFDA. This site is unofficial and independent of the FDA.