Print-ready dossier — use your browser's print dialog to save as PDF.
Hillrom™
Model 4058110 · Baxter Medical Systems GmbH + Co. KG · DI 00887761986084
KZF — Device, Medical Examination, Ac Powered · Class I · 21 CFR 880.6320
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (4)
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.
Malfunction: 4
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-03
0
1
2019-04
0
1
2019-05
0
2
2019-07
0
2
2019-08
0
2
2019-09
0
3
2019-11
0
1
2019-12
0
4
2020-03
0
1.1
2020-05
0
1
2020-07
3
2
2020-09
0
1
2020-10
0
1
2021-02
0
2
2021-03
0
2
2021-04
0
1
2021-06
0
2
2021-08
0
3
2021-10
0
3
2021-12
0
1
2022-01
0
1
2022-05
0
1
2022-07
0
10
2022-08
0
1
2022-09
0
1
2022-11
0
1
2023-03
0
2
2023-04
0
1
2023-05
1
1
2023-06
0
1
2023-08
0
1
2023-09
0
2
2023-10
0
3
2023-11
0
1
2023-12
0
1
2024-01
0
1
2024-02
0
1
2024-03
0
1
2024-04
0
1
2024-05
0
1
2025-02
0
2
2025-07
0
1.75
2025-08
0
1.75
2025-10
0
1.33
2025-12
0
1.75
2026-03
0
8
2026-04
0
1.8
This device (reports/month)Average device in KZF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Baxter Medical Systems GmbH + Co. KG