Recall Z-0706-2024 ยท DPS Electrocardiograph
Baxter Healthcare Corporation
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 XML, XSCRIBE-6AA-AAAAA; f) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX; g) XS6 WAM TTL SYS Z
| Date | Jan 10, 2024 (initiated Dec 8, 2023) |
| Status | Open, Classified |
| Reason | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. |
| Root cause | Software design |
| Action | Baxter issued an Urgent Medical Device Correction notice to its consignees on 12/08/2023 via USPS first class mail. The notice explained the problem, hazard involved, requested the following actions be taken until a software update becomes available: - Clinicians should evaluate the potential impact of the SCF as described to determine if it should be enabled or disabled during stress testing and provided the method for disabling the setting. - If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them, infor |
| Quantity | 2985 units |
| Distribution | United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems Mortara Instrument, Inc., Jan 6, 2016 |