Food, drugs, devices › Baxter Healthcare Corporation
Device recall: Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633
Baxter Healthcare Corporation (Deerfield, IL) initiated this device recall on 19 Sep 2024; FDA lists 9 product records under event 95409, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Baxter Healthcare Corporation has 193 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Baxter Healthcare Corporation, Deerfield, IL.
Reason for recall
"The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke."
Distribution
"Worldwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0210-2025 | Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633 | 6045 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0211-2025 | Baxter Operating Table TruSystem 7000, Product code REF 1841046 | 397 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0212-2025 | Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 | N/A | Class II | Ongoing | 30 Oct 2024 |
| Z-0213-2025 | Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 | 1077 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0214-2025 | Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 | 4 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0215-2025 | Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 | 24 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0216-2025 | Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083 | N/A | Class II | Ongoing | 30 Oct 2024 |
| Z-0217-2025 | Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 | 542 units | Class II | Ongoing | 30 Oct 2024 |
| Z-0218-2025 | Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 | 13 units | Class II | Ongoing | 30 Oct 2024 |
Context
Other enforcement events for Baxter Healthcare Corporation
All 193 events for Baxter Healthcare Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.