Recall Z-2384-2012— Philips Healthcare Inc.

Name: FDA recall Z-2384-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-14

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-08-14, terminated 2017-01-17. It names one FDA 510(k) clearance: K982795. Product: Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications. Reason: Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm..

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-14
Terminated: 2017-01-17
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K982795 — PHILIPS BUCKY VISIONPhilips Medical Systems, Inc.·cleared 1998-11-24

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

Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

Reason for recall

Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.

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