Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Summary
The FDA issued a Class II for Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -M by Zoe Medical Incorporated. Reason: This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended .
Details
Source
Device Recall
External ID
Z-3099-2024
Action Date
2024-09-18
Status
Ongoing
Category
device
Product Description
Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331
Lot/Code Info: 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
Quantity Affected: 1506 units
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.
Distribution
awaiting additional details
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-13
Company
Topsfield, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Zoe Medical Incorporated has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zoe Medical Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zoe Medical Incorporated have FDA actions?
Zoe Medical Incorporated has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3099-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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