Sentinel V10 — Class II medical device recall Z-0563-2021
Terminated recall by Spacelabs Healthcare, Ltd., reported 2020-12-16, distributed nationwide. During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP
| Recall number | Z-0563-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Ltd., Hertford, N/A, United Kingdom |
| Recall initiated | 2020-11-06 |
| Classified | 2020-12-10 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2024-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BE, BO, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FR, GB, GR, GT, HK, HR, IE, IL, IN, IR, IS, IT, KE, KR, KW, KY, LB, LT, MA, MX, NI, NL, OM, PA, PE, PK, PL, PT, PY, QA, RS, SA, SE, SG, SI, SK, SV, TH, TN, TR, TW, UY, VE, ZA |
| Quantity | 600 |
| Model numbers | 98200, 98201 |
Product
Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.
Reason for recall
During system upgrade incorrect comments may be added to existing tests. In such instance: Resting ECG and ABP tests which did not contain comments at the time of the upgrade, may have unrelated comments added. Existing comments will not be overwritten or removed. Rhythm ECG Tests may have comments overwritten with unrelated comments. Any tests created after the upgrade are not affected.
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-0563-2021. 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.