Recall Z-1074-2014— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1074-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-19

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2013-12-19, terminated 2015-01-12. It names one FDA 510(k) clearance: K080927. Product: Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.. Reason: Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As.

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Terminated: 2015-01-12
Firm location: Cleveland, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K080927 — BRIGHTVIEW VCT IMAGING SYSTEMPhilips Medical Systems (Cleveland), Inc.·cleared 2008-04-11

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

Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies.

Reason for recall

Three problems were reported to the firm: When positioning for a relative 180 degree non circular acquisition the second (bottom) detector was not positioned correctly causing an inappropriate rotation orbit calculation. When the acquisition was started and the detectors began to move into position, the incorrect calculation resulted in the detectors coming in contact with the patient. As

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