Data Foundry

Medical device recalls 2026

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL… — Class II medical device recall Z-2052-2026

Ongoing recall by Spacelabs Healthcare, Inc., reported 2026-05-13, distributed nationwide. Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

Recall numberZ-2052-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSpacelabs Healthcare, Inc., Snoqualmie, WA, United States
Recall initiated2026-03-26
Classified2026-05-01
Reported by FDA2026-05-13
DistributedNationwide (US)
Countries outside the USAR
Quantity57
Reason classespackaging, device malfunction
UPC / GTIN / UDI-DI10841522106422
Serial numbers1496-224657, 1496-224658, 1496-224659, 1496-224660, 1496-224661, 1496-224664, 1496-224665, 1496-224666, 1496-224667, 1496-224668, 1496-224669, 1496-224670, 1496-224671, 1496-224673, 1496-224674, 1496-224675, 1496-224676, 1496-224677, 1496-224678, 1496-224679, 1496-224680, 1496-224681, 1496-224682, 1496-224683, 1496-224684 and 31 more
Model numbers91496

Product

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A

Reason for recall

Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).

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-2052-2026. 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.