Data Foundry

Medical device recalls 2026

Multi-parameter Command Module — Class II medical device recall Z-1793-2026

Ongoing recall by Spacelabs Healthcare, Inc., reported 2026-04-15, distributed nationwide. Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measuremen

Recall numberZ-1793-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSpacelabs Healthcare, Inc., Snoqualmie, WA, United States
Recall initiated2026-02-27
Classified2026-04-07
Reported by FDA2026-04-15
DistributedNationwide (US)
Countries outside the USAR, CA, FR, KW, MX, PA, PK, PL, SA, TW
Quantity1,790
UPC / GTIN / UDI-DI10841522106415, 10841522106422
Serial numbers10841522106415, 10841522106422, 1496, 1496-005908, 1496-010295, 1496-014881, 1496-014884, 1496-014895, 1496-020263, 1496-020462, 1496-034574, 1496-101134, 1496-103164, 1496-116983, 1496-123122, 1496-139989, 1496-140522, 1496-142064, 1496-152103, 1496-152116, 1496-152331, 1496-152369, 1496-159546, 1496-159552, 1496-162049 and 475 more
Model numbers91496

Product

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

Reason for recall

Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.

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-1793-2026. 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.