Monica Novii Wireless Patch System product Usage: Novii Interface - The Novii Interface is an accessory to the Novii Pod

FDA device recall Z-2588-2017 · posted 2017-05-25 · Terminated

Recall details

Recalling firm

MONICA HEALTHCARE LTD

Reason for recall

Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.

Action taken

The recall strategy outlined below addresses the depth of the recall, plan for public notification, and recall notification (customer letter) effectiveness check. This issue will be resolved by sending an Urgent Medical Device Correction customer letter (attached) to customers with affected units. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to correct all affected Products at no cost to the customer. The plan for public notification is to contact all customers with affected systems by means of an Urgent Medical Device Correction via e-mail. This letter will be sent to the following titles within the affected accounts: Nurse Managers, Labor & Delivery/Bio-medical Engineering Department Managers/Risk Management Directors. We will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OSP

Quantity affected

4,110 (4,106 US; 4 OUS)

Distribution

The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.

Date initiated

2017-04-28

Date posted

2017-05-25

Date terminated

2018-03-01

Location

Nottingham, United Kingdom

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