Device recall
Z-0706-2024: XScribe Cardiac Stress Testing System, version 6, with below product names and…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-0706-2024 |
|---|---|
| Recall event | 93209 |
| Product | XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6 WAM TTL SYS Z200 AHA… |
| 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