NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
FDA device recall Z-1223-2022 · posted 2022-06-02 · Open, Classified
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- Software anomaly was identified.
- Action taken
- The firm issued a recall notification to consignees on 05/03/2022 via mail. The letter instructs the consignee to follow the IFU regarding the setup and "Lead Off Detected" error message, forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed, and to complete the response form. An additional correction notification was sent on about 09/13/2023 to notify consignees of the update availability (NIM Vital" SW version v1.4.3) to fix this issue.
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- GWF
- Quantity affected
- 18 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TX, CO, NJ and the country of France.
- Date initiated
- 2022-05-03
- Date posted
- 2022-06-02
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NIM Vital, Nerve Integrity Monitor (K200759) | Medtronic Xomed, Inc. | 2020-10-28 |