Recall Z-3099-2024— Zoe Medical Incorporated

Name: FDA recall Z-3099-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-13

Class II · Ongoing

Class II FDA medical device recall by Zoe Medical Incorporated, initiated 2024-08-13. It names one FDA 510(k) clearance: K150620. Product: Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331. 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..

Recalling firm: Zoe Medical Incorporated
Classification: Class II
Status: Ongoing
Initiated: 2024-08-13
Firm location: Topsfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K150620 — 740 SELECTCas Medical Systems, Inc.·cleared 2015-05-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.