DM4 recallZ-3099-2024 · Zoe Medical Incorporated · initiated Aug 13, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zoe Medical Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling design
What the company is doing
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
Recall details
- Recall number
- Z-3099-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 13, 2024
- Posted by the FDA
- Sep 10, 2024
- Recalling firm
- Zoe Medical Incorporated
- Quantity
- 1506 units
- Product code
- DQA
- FDA submissions
- K150620
- Distribution
- awaiting additional details
Product description
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Code information (models, lots, serial numbers)
Model No. 91331-M; UDI-DI 00851920007347; all serial numbers up to GFD10486 Model No. 91331-MF; UDI-DI 00851920007354; all serial numbers up to GFD10486 Model No. 91331-N; UDI-DI 00851920007309; all serial numbers up to GFD10486 Model No. 91331-NF; UDI-DI 00851920007316; all serial numbers up to GFD10486 Model No. 91331-MW; UDI-DI 00851920007361; all serial numbers up to GFD10486 Model No. 91331-MFW; UDI-DI 00851920007378; all serial numbers up to GFD10486 Model No. 91331-NW; UDI-DI 00851920007323; all serial numbers up to GFD10486 Model No. 91331-NFW; UDI-DI 00851920007330; all serial numbers up to GFD10486
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- DM4 91331-NZoe Medical Incorporated · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-NFZoe Medical Incorporated · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-NWZoe Medical Incorporated · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-NFWZoe Medical Incorporated · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-MZoe Medical Incorporated · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-MFZoe Medical Incorporated · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-MWZoe Medical Incorporated · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
- DM4 91331-MFWZoe Medical Incorporated · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 95160).
- Z-3098-2024 · Open, ClassifiedSpacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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