Spacelabs Ultraview DM3 (Zoe Medical) - Battery Risk (2024)
Inadequate battery warning labeling can increase risks associated with battery use.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Brand
Zoe Medical Incorporated
Lot Codes / Batch Numbers
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
Products Sold
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
Zoe Medical Incorporated is recalling Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330 due to This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026