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Head-Positioning accessories
Model 1739994 · Baxter Medical Systems GmbH + Co. KG · DI 00887761972780
GDC — Table, Operating-Room, Electrical · Class I · 21 CFR 878.4960
JEA — Table, Surgical With Orthopedic Accessories, Ac-Powered · Class I · 21 CFR 878.4960
KXJ — Table, Radiologic · Class II · 21 CFR 892.1980
UDILibrary device dossier · generated 2026-09-16 · 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
2026-04-21
Z-2638-2026
Class II
Open, Classified
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.
code info di
Adverse-event reports — MAUDE (2)
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: 2
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
3.25
2019-02
0
4
2019-03
0
1.5
2019-04
0
3
2019-05
0
2.4
2019-06
0
2
2019-07
0
3.33
2019-08
0
3.83
2019-09
0
2.5
2019-10
0
3.17
2019-11
0
3
2019-12
0
3.4
2020-01
0
2.78
2020-02
0
2.17
2020-03
0
3.67
2020-04
0
3.33
2020-05
0
3
2020-06
0
4.78
2020-07
0
35
2020-08
0
20
2020-09
0
21
2020-10
0
13.6
2020-11
0
47.5
2020-12
0
9.88
2021-01
0
9.14
2021-02
0
14.33
2021-03
0
14.25
2021-04
0
11.09
2021-05
0
12
2021-06
0
6
2021-07
0
1.63
2021-08
0
1
2021-09
0
1
2021-10
0
1.25
2021-11
0
1.64
2021-12
0
1.33
2022-01
0
1.6
2022-02
0
6.6
2022-03
0
1.86
2022-04
0
1.67
2022-05
0
1.4
2022-06
0
2.14
2022-07
0
1.29
2022-08
0
1.09
2022-09
0
2.17
2022-10
0
1.64
2022-11
0
1.5
2022-12
0
1.54
2023-01
0
2
2023-02
0
2
2023-03
0
2
2023-04
0
1.26
2023-05
0
2.14
2023-06
0
2.75
2023-07
0
1.5
2023-08
0
1.57
2023-09
0
1.36
2023-10
0
1.83
2023-11
0
1.44
2023-12
0
1.7
2024-01
0
1.92
2024-02
0
2.89
2024-03
0
1.73
2024-04
0
2.33
2024-05
0
2.22
2024-06
0
2.57
2024-07
0
2.31
2024-08
0
4.25
2024-09
0
2.13
2024-10
0
3.42
2024-11
0
3.71
2024-12
0
2.57
2025-01
0
2
2025-02
0
3.58
2025-03
0
5.86
2025-04
0
1.75
2025-05
0
1.8
2025-06
0
2.13
2025-07
0
1.61
2025-08
0
1.75
2025-09
0
1
2025-10
0
2
2025-11
0
2
2025-12
0
1.1
2026-01
0
2.2
2026-02
0
1.5
2026-03
1
2.43
2026-04
0
1.79
2026-05
0
2.17
2026-06
1
1.5
This device (reports/month)Average device in GDC, JEA, KXJ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Baxter Medical Systems GmbH + Co. KG