Device recall
Z-0705-2024: Q-Stress Cardiac Stress Testing System, version 6, with below product name /…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-0705-2024 |
|---|---|
| Recall event | 93209 |
| Product | Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML /… |
| Product code | DPS |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K152944 |
| FEI number | 1417572 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database