Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

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.

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