Spacelabs Healthcare Smart Disclosure System — Class II medical device recall Z-2035-2019
Terminated recall by Spacelabs Healthcare, Inc., reported 2019-07-31, distributed nationwide. Several reports were received that patient records were printed with the correct patient demographics but cont
| Recall number | Z-2035-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare, Inc., Snoqualmie, WA, United States |
| Recall initiated | 2019-01-28 |
| Classified | 2019-07-22 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2022-02-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BH, BO, BR, CA, CH, CL, CN, CR, CZ, ES, FR, GB, HK, ID, IN, IT, KW, KY, MX, MY, NL, PA, PH, PK, PL, QA, RO, SA, TN, TR, TT, TW, VN |
| Quantity | 295 customer |
| UPC / GTIN / UDI-DI | 10841522123580 |
| Model numbers | 92810 |
Product
Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.
Reason for recall
Several reports were received that patient records were printed with the correct patient demographics but containing another patient's waveforms.
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-2035-2019. 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.