Z-3098-2024Class II

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

Name: Z-3098-2024 Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Creator: Zoe Medical Incorporated
Published: 2024-08-13
License: https://open.fda.gov/license/

Zoe Medical, Inc. / initiated 2024-08-13 / Open, Classified / root cause: labeling and UDI

FDA source

Zoe Medical Incorporated began a recall of Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330 on 2024-08-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3098-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-13
Posted: 2024-09-10
Recalling firm: Zoe Medical, Inc.
Product: Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Product code: DQA Oximeter
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 6429 units
Distribution: awaiting additional details
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3098-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3098-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10
Z-3099-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-18	2024-09-10

Product code DQA

K093802Class IIUltraview Dm3 MonitorZoe Medical, Inc. / cleared 2010-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)