Recall Z-1307-2015— Philips Medical Systems, Inc.

Name: FDA recall Z-1307-2015
Creator: U.S. Food and Drug Administration
Published: 2014-11-20

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-11-20, terminated 2017-01-23. It names one FDA 510(k) clearance: K052078. Product: Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2 Module used with the Precess MRI Compatible Patient Monitoring System, Philips Basic Triggering Set, Philips Monitoring Sensor Set, Philips Battery Set. Reason: VCG battery ignited in a VCG unit when recharging..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Terminated: 2017-01-23
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K052078 — ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIESPhilips Medical Systems Nederland B.V.·cleared 2005-09-07

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

Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring System, Wireless SpO2 Module used with the Precess MRI Compatible Patient Monitoring System, Philips Basic Triggering Set, Philips Monitoring Sensor Set, Philips Battery Set

Reason for recall

VCG battery ignited in a VCG unit when recharging.

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