XScribe CP Cardiac Stress Testing System — Class II medical device recall Z-0707-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-01-17, distributed in GA, PR. Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) i
| Recall number | Z-0707-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-12-08 |
| Classified | 2024-01-10 |
| Reported by FDA | 2024-01-17 |
| Distributed | GA, PR |
| Countries outside the US | AE, AR, AT, AU, BD, BG, BH, BO, BR, BS, CA, CH, CL, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IS, IT, JO, KE, KR, KW, LB, LK, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, RU, SA, SG, TH, TN, TR, TT, ZA |
| Quantity | 1,675 units |
| UPC / GTIN / UDI-DI | 00110120039429, 00110120039436, 00110190044569, 00110200045838, 00110230049219, 00110260052821, 00110280053723, 00110410060508, 00110420061168, 00110440063043, 00110460064709, 00110460064754, 00111060071715, 00111200081338, 00111200081536, 00111300088626, 00111340091242, 00111360092144, 00111420097843, 00111450099473, 00111460100428, 00111530104950, 00112030106628, 00112130112154, 00112180115631 and 135 more |
| NDC | 41000-0030-50, 41000-0030-51, 41000-0030-52, 41000-0030-53, 41000-0030-60, 41000-0030-62, 41000-0030-64 |
| Serial numbers | 10081765502005100, 110120039363, 110120039364, 110120039425, 110120039426, 110120039427, 110120039428, 110120039429, 110120039430, 110120039431, 110120039432, 110120039433, 110120039434, 110120039435, 110120039436, 110120039437, 110120039438, 110120039439, 110190044556, 110190044557, 110190044558, 110190044559, 110190044560, 110190044561, 110190044562 and 475 more |
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 for recall
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0707-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.