Data Foundry

Medical device recalls 2023

Ultraview SL — Class II medical device recall Z-1503-2023

Ongoing recall by Spacelabs Healthcare, Inc., reported 2023-05-10, distributed nationwide. Command modules will display the following when parameter processing is suspended, depending on software versi

Recall numberZ-1503-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSpacelabs Healthcare, Inc., Snoqualmie, WA, United States
Recall initiated2023-04-12
Classified2023-05-03
Reported by FDA2023-05-10
DistributedNationwide (US)
Quantity1,088
Reason classessoftware
Model numbers91496

Product

Ultraview SL (UVSL) Command Module, Model 91496

Reason for recall

Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present with no alarms, 2) Newer versions have waveforms absent with no alarms. This may cause clinicians to miss a potentially catastrophic event.

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-1503-2023. 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.