Recall Z-3098-2024
Zoe Medical Incorporated · initiated August 13, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
Codes / 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
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.
FDA-determined cause: Labeling design
Action taken
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
Details
- Recall number
- Z-3098-2024
- Initiated
- August 13, 2024
- Posted by FDA
- September 10, 2024
- Product code
- DQA – Oximeter
- Quantity
- 6429 units
- Distribution
- awaiting additional details
- Recalling firm
- Zoe Medical Incorporated, Topsfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3099-2024 Class II | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW…This product labeling does not adequately provide warning about the risks associated with the use of damaged… | 08/13/2024Open, Classified |