Case Cardiac Assessment System for Exercise Testing and CardioSoft… — Class II medical device recall Z-1927-2021
Terminated recall by GE Healthcare, LLC, reported 2021-06-30, distributed nationwide. If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a differ
| Recall number | Z-1927-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2021-04-19 |
| Classified | 2021-06-22 |
| Reported by FDA | 2021-06-30 |
| Terminated | 2026-01-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HK, HN, HU, ID, IE, IL, IN, IQ, IT, JM, JO, JP, KE, KR, KW, KY, LB, LK, LT, LV, MT, MX, MY, NL, NO, NZ, OM, PA, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, UY, VN, ZA |
Product
Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application
Reason for recall
If a certain sequence of events occur, the pdf test report that belongs to one patient will appear in a different patient's record when viewed in an Electronic Medical Record (EMR) or a similar system.
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-1927-2021. 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.