A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

FDA device recall Z-2226-2023 · posted 2023-07-21 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.

Action taken

Only one of the two consignees received the notification since one of the consignees independently updated their tablet. On 6/22/2023, the notification dated June 2023 was issued to the consignee via visit by the sales representative. The notification described the issue and provided required actions which included: (1) Update the A901 Comm Manager application to version 1.0.1239 on the clinician programmer (tablet), serial #NPL3011706, using the instructions listed in Appendix A, Updating Clinician Programmer Software; (2) Complete the Customer Confirmation Form enclosed with the letter acknowledging that the consignee has received this information; and (3) Share this notice with all those who need to be aware of the issue within the organization and maintain a copy of it in the records.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LGW

Quantity affected

2 clinician tablets

Distribution

International distribution to the countries of Israel and Serbia.

Date initiated

2023-06-21

Date posted

2023-07-21

Location

Minneapolis, MN