Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
5 linked reportsMalfunction 5
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
2
2019-02
0
1
2019-03
0
1.5
2019-04
0
1
2019-05
0
2
2019-06
0
1.5
2019-07
0
3
2019-08
0
1
2019-09
0
2.5
2019-11
0
5
2019-12
0
2.5
2020-01
0
2.5
2020-02
0
1
2020-03
0
2
2020-04
0
3
2020-05
0
4
2020-06
0
7.67
2020-07
0
35
2020-08
0
28
2020-09
0
38
2020-10
0
28
2020-11
0
47.5
2020-12
0
16.75
2021-01
0
10.5
2021-02
0
23.2
2021-03
0
20.8
2021-04
0
16.67
2021-05
0
13.83
2021-06
0
7.5
2021-07
0
1.4
2021-08
0
1
2021-09
0
1
2021-10
0
1
2021-11
0
1.4
2021-12
0
1.4
2022-01
0
1
2022-02
0
6.6
2022-03
0
2.33
2022-04
0
2
2022-05
0
1.67
2022-06
0
2.75
2022-07
0
1.4
2022-08
0
1
2022-09
0
2.75
2022-10
0
2
2022-11
0
1.67
2022-12
0
1.56
2023-01
0
3
2023-02
0
2
2023-03
0
1.86
2023-04
0
1.18
2023-05
0
2.23
2023-06
0
2.78
2023-07
0
2
2023-08
0
1.75
2023-09
0
1.5
2023-10
0
2
2023-11
0
1.2
2023-12
0
1.43
2024-01
0
2.25
2024-02
0
2.86
2024-03
0
1.38
2024-04
0
2
2024-05
0
2.08
2024-06
0
2.33
2024-07
0
1
2024-08
0
3.29
2024-09
0
1.88
2024-10
1
3
2024-11
0
3.42
2024-12
0
2.5
2025-01
0
2
2025-02
0
3.6
2025-03
0
5.25
2025-04
0
1
2025-05
0
1.33
2025-06
1
2.2
2025-07
0
1.54
2025-08
0
1.64
2025-09
0
1
2025-10
0
1.67
2025-11
2
1.62
2025-12
0
1.13
2026-01
0
1.5
2026-02
1
1.57
2026-03
0
2
2026-04
0
1.46
2026-05
0
1.33
2026-06
0
1.13
This device (reports/month)Average device in GDC, KXJ (reports/device/month)
Failure-mode summaryAI-generated
5 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2024-06-28
Z-2512-2024
Class II
Open, Classified
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table. This could potentially result in unintentional patient movement during surgical procedures and/or preparation for surgical procedures, including transport.Distribution: Worldwide distribution - US Nationwide and the country of Canada.