Z-0971-2009

3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and...

Name: Z-0971-2009 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and...
Creator: Invivo Corporation
Published: 2008-08-13
License: https://open.fda.gov/license/

Invivo Corporation / initiated 2008-08-13 / Terminated / root cause: manufacturing process

FDA source

Invivo Corporation began a recall of 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo... on 2008-08-13. The reason FDA records is "Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, when dropped from 3...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0971-2009
Status: Terminated
Initiated: 2008-08-13
Posted: 2009-02-06
Terminated: 2010-11-19
Recalling firm: Invivo Corporation
Product: 3.7 V Li-Polymer Battery, used in Precess MRI Compatible Patient Monitoring System and Achieva, Intera and Panorama 1.0T. REF 9065 or REF 9067. Invivo Corporation, Orlando, FL 32826 These rechargeable batteries are used to supply power to patient monitoring system's wireless modules and gating/triggering systems' fiber optic modules.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, when dropped from 3 feet/1 meter onto a hard surface can produce a flame and then emit smoke. The firms investigation shows that the battery failure does not occur when a module is dropped with a ba
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Urgent Medical Device Recall Notice letters, dated August 2008, and response forms were mailed to each consignee. Distributors were instructed to forward copies of the recall letter and response forms to their customers. The letters identified the affected products, gave the reason for the recall, the hazard involved, how to identify the product, actions to prevent the failure, and procedures to mitigate risk if failure occurs. The letter stated that Invivo would provide replacement batteries but until replacements were provided, customers should handle batteries over an elevated area and to make sure batteries are handled in the absence of paper or other flammable materials. If customers wish to remove the battery from the module in order to conserve battery life, they are to disengage the battery from the module and place the battery on a table or in the battery charger. Do not allow the battery to be disengaged and remain partially inserted in the module as this may cause the battery to slip from the module and fall to the floor.
Quantity in commerce: 8,476
Distribution: Worldwide Distribution
Product codes and lots: date codes 2808 and lower.

Product code MWI

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)