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DM4
Model 91331-M · ZOE MEDICAL INCORPORATED · DI 00851920007347
MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.2300
UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2024-08-13
Z-3099-2024
Class II
Open, Classified
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.
code info di
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1
2019-02
0
1
2019-03
0
1.25
2019-04
0
2
2019-05
0
1.4
2019-06
0
1.29
2019-07
0
1.25
2019-08
0
1.33
2019-09
0
1.33
2019-10
0
2
2019-11
0
1.29
2019-12
0
1
2020-01
0
1
2020-02
0
1.4
2020-03
0
1.5
2020-04
0
1.33
2020-05
0
1.5
2020-06
0
1.57
2020-07
0
2
2020-08
0
2.5
2020-09
0
1.5
2020-10
0
1.83
2020-11
0
1.8
2020-12
0
1.33
2021-01
0
1
2021-02
0
1
2021-03
0
1.4
2021-04
0
2.17
2021-05
0
2.5
2021-06
0
1.25
2021-07
0
1.89
2021-08
0
2.43
2021-09
0
1.86
2021-10
0
2
2021-11
0
1.75
2021-12
0
1.56
2022-01
0
1.27
2022-02
0
1.6
2022-03
0
1.17
2022-04
0
1.6
2022-05
0
2.4
2022-06
0
1.67
2022-07
0
1.25
2022-08
0
1.67
2022-09
0
2
2022-10
0
1.63
2022-11
0
1.67
2022-12
0
1.86
2023-01
0
2
2023-02
0
2.25
2023-03
0
3.25
2023-04
0
3.78
2023-05
0
1.2
2023-06
0
2.25
2023-07
0
1.67
2023-08
0
2.86
2023-09
0
3.4
2023-10
0
1.8
2023-11
0
1
2023-12
0
1.5
2024-01
0
2
2024-02
0
2.8
2024-03
0
4.67
2024-04
0
1.33
2024-05
0
3.17
2024-06
0
2
2024-07
0
1.71
2024-08
0
3
2024-09
0
2.2
2024-10
0
2.8
2024-11
0
1.57
2024-12
0
7.2
2025-01
0
1
2025-02
0
2.67
2025-03
0
1.6
2025-04
0
2.43
2025-05
0
4.5
2025-06
0
5.33
2025-07
0
4.4
2025-08
0
5
2025-09
0
2.5
2025-10
0
6.4
2025-11
0
3.57
2025-12
0
2.77
2026-01
0
2.29
2026-02
0
2.86
2026-03
0
4.83
2026-04
0
7.17
2026-05
0
7.54
2026-06
0
7.92
This device (reports/month)Average device in MWI (reports/device/month)