Recall Z-2009-2019— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-2009-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-10

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2019-06-10, terminated 2020-07-24. It names one FDA 510(k) clearance: K080927. Product: BrightView SPECT, Model Number 882480. Reason: An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2019-06-10
Terminated: 2020-07-24
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

BrightView SPECT, Model Number 882480

Reason for recall

An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.

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