Recall Z-3099-2024 ยท DQA Oximeter
Zoe Medical Incorporated
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
| Date | Sep 10, 2024 (initiated Aug 13, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 1506 units |
| Distribution | awaiting additional details |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150620 | 740 SELECT Cas Medical Systems, Inc., May 8, 2015 |