Recall Z-1481-2013— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1481-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-25

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-04-25, terminated 2014-02-12. It names one FDA 510(k) clearance: K062298. Product: BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.. Reason: Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Terminated: 2014-02-12
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K062298 — APOLLO GAMMA CAMERA SYSTEMAdac Laboratories·cleared 2006-08-23

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

BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed Tomography (ECT) studies.

Reason for recall

Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.

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