FDA Device recall Z-0707-2024
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-03…
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-03… by Baxter Healthcare, citing potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0707-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-08 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | GA, PR |
Product
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) XSCRIBE CP SW KIT, 41000-030-64
Reason
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Identifiers
| code_info | Product Code, UDI/DI Number, Serial Numbers a) 41000-030-50, UDI/DI None, Serial Numbers: 110120039437, 110120039438,…Product Code, UDI/DI Number, Serial Numbers a) 41000-030-50, UDI/DI None, Serial Numbers: 110120039437, 110120039438, 110120039439, 110190044556, 110190044557, 110190044558, 110190044559, 110190044560, 110190044561, 110190044562, 110190044563, 110190044564, 110190044565, 110190044566, 110190044567, 110200045831, 110200045832, 110200045833, 110200045834, 110200045835, 110260052818, 110260052819, 110260052820, 110260052821, 110260052822, 110260052823, 110420061166, 110420061167, 110420061168, 110420061169, 110460064753, 110460064754, 110460064755, 110460064697, 110460064698, 110460064699, 110460064700, 110460064702, 110460064703, 110460064704, 110460064705, 110460064706, 111150077803, 111150077804, 111150077805, 111150077806, 111150077807, 111150077808, 111150077809, 111200081334, 111200081335, 111200081336, 111200081337, 111200081338, 111200081339, 111200081340, 111200081341, 111300088621, 111300088622, 111300088623, 111300088624, 111300088625, 111300088626, 111300088627, 111340091242 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0707-2024%22
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