Zoe Medical Incorporated: Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

Recall number

Z-3098-2024

Recalling firm

Zoe Medical Incorporated

Product

Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

Status

Open, Classified

Initiated

2024-08-13

Posted

2024-09-10

Terminated

not on file

Reason

This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.

Root cause

Labeling design

Action

An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to customers on 8/13/24. Actions being taken by Spacelabs Healthcare: The Operations Manual and Service Manual for the DM3 and DM4 have been updated to convey the risks associated with continuing to use the lithium batteries past the specified use life and to clarify that batteries older than two years, damaged, or that are no longer holding a charge must be replaced. Actions to be implemented by users: Users must download current versions of the Operations Manual and Service Manual and dispose of any previous copies. The updated product labeling is available via the Spacelabs user manual site at https://manuals.spacelabshealthcare.com/. Biomedical engineering must remove and replace any batteries that have been in use longer than two years, are damaged, or are no longer holding a charge. Contact Spacelabs Service to arrange for battery replacement. Use only manufacturer-supplied batteries. Biomedical engineering must arrange preventive maintenance to replace the batteries upon reaching the conclusion of their two-year use life. Acknowledgement Requested: Spacelabs requests that all customers acknowledge receipt and understanding of this notification by either mailing the included PDF copy of the response form or by completing the online form which can be accessed by using either the URL below or scanning the QR code: https://spacelabshealthcare.com/support/recall-reply-form/recall-reply-form-dm3-dm4-battery-life/ Please pass this notice on to those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. For additional information or technical assistance, please contact: Spacelabs Technical Support Spacelabs Healthcare, Inc 35301 SE Center Street Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support

Quantity

6429 units

Distribution

awaiting additional details

Lot, serial or model codes

Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330; no UDI-DI (distributed prior to UDI regulation); all serial numbers up to FFD8292 Model No. 91330-M; UDI-DI 00851920007002; all serial numbers up to FFD8292 Model No. 91330-MT; UDI-DI 00851920007019; all serial numbers up to FFD8292 Model No. 91330-N; UDI-DI 00851920007026; all serial numbers up to FFD8292 Model No. 91330-NT; UDI-DI 00851920007033; all serial numbers up to FFD8292

510(k) numbers

["K093802"]

PMA numbers

not on file

Product code

DQA

Firm FEI

3003294644

Firm city

Topsfield

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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