91496 Ultraview SL Command Module — Class II medical device recall Z-2343-2016
Terminated recall by Spacelabs Healthcare Inc, reported 2016-08-10. The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functi
| Recall number | Z-2343-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spacelabs Healthcare Inc, Snoqualmie, WA, United States |
| Recall initiated | 2016-07-01 |
| Classified | 2016-08-04 |
| Reported by FDA | 2016-08-10 |
| Terminated | 2017-05-22 |
| Countries outside the US | AE, AF, AR, AU, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DO, EC, EE, EG, ES, FR, GB, GT, HK, IL, IN, IR, IT, JO, KW, KY, LK, MA, MX, NI, NL, PA, PE, PH, PK, PL, PT, QA, RO, SA, SK, TN, TR, TT, TW, UY, VN |
| Lot numbers | 128280, 129420, 129940, 155640 |
Product
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.
Reason for recall
The firm has received multiple reports of the Non-Invasive Blood Pressure (NIBP) parameter becoming non-functional with an associated message (No Reading). In addition, there is one of the following three error messages: Inflate Error, HW Error, or No Data.
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-2343-2016. 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.