Z-1307-2015Class II

Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065...

Name: Z-1307-2015 Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065...
Creator: Philips Medical Systems, Inc.
Published: 2014-11-20
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-11-20 / Terminated / root cause: design

FDA source

Philips Medical Systems, Inc. began a recall of 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... on 2014-11-20. FDA classified it as Class II and gives the reason as "VCG battery ignited in a VCG unit when recharging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1307-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-20
Posted: 2015-03-20
Terminated: 2017-01-23
Recalling firm: Philips North America LLC
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
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: VCG battery ignited in a VCG unit when recharging.
Root cause tag: design
FDA root cause: Component design/selection
Action: Consignees were informed of the recall via letter sent on November 20, 2014 via certified mailing. Field Service Engineers (FSE) will replace all affected batteries.
Quantity in commerce: 79
Distribution: Distributed in the following states: AL, CA, FL, GA, IL, MA, MN, NC, ND, NE, NJ, NY, OH, OR, PA, TN, TX, UT, WA, WI; OUS: Australia, Austria, Belgium, China, Ecuador, Finland, France, Germany, Italy, Japan, Mexico, Netherlands, slovenia, South Africa, Sweden, Switzerland, United Kingdom
Product codes and lots: Batteries with date codes 2808 or earlier.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1307-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1307-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-20

Product code LNH

K052078Class IIAchieva, Intera and Panorama 1.0 Release 2-SeriesPhilips Medical Systems Nederland B.V. / cleared 2005-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)