Recall Z-0971-2009 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
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.
| Date | Feb 6, 2009 (initiated Aug 13, 2008) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 8,476 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |