Recall Z-0707-2024 ยท DPS Electrocardiograph
Baxter Healthcare Corporation
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 41000-030-53; e) XSCRIBE CP KIT WIRELESS, 41000-030-60; f) XSCRIBE CP KIT WIRED, 41000-030-62; g) X
| 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 | 1675 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
This recall record lists no 510(k) number.