Recall Z-1791-2015— Philips Medical Systems (Cleveland) Inc

Name: FDA recall Z-1791-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-06

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2015-03-06, terminated 2017-03-13. It names one FDA 510(k) clearance: K062298. Product: BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.. Reason: The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes..

Recalling firm: Philips Medical Systems (Cleveland) Inc
Classification: Class II
Status: Terminated
Initiated: 2015-03-06
Terminated: 2017-03-13
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 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

Reason for recall

The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

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