Recall Z-2681-2016— Philips Electronics North America Corporation

Name: FDA recall Z-2681-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-12

Class II · Terminated

Class II FDA medical device recall by Philips Electronics North America Corporation, initiated 2016-08-12, terminated 2020-07-15. It names one FDA 510(k) clearance: K964124. Product: PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).. Reason: A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing..

Recalling firm: Philips Electronics North America Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-08-12
Terminated: 2020-07-15
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K964124 — PHILIPS COMPUTED RADIOGRAPHYPhilips Medical Systems, Inc.·cleared 1996-12-18

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

PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).

Reason for recall

A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.

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