Ultraview SL Ultraview SL®Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841522106422), received between Sep 2, 2025 and Feb 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

12 other recalls cover devices cleared under the same FDA submission (K103142); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Mar 26, 2026Class IIOpen, Classified

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

   Z-2052-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Feb 27, 2026Class IIOpen, Classified

   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.

   Z-1793-2026 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Intermittent Communication Failure

  THE CUSTOMER CONTACTED SPACELABS HEALTHCARE TO REPORT THAT PATIENT PARAMETERS WERE INTERMITTENTLY DROPPED WHILE A ULTRAVIEW COMMAND MODULE WAS IN USE. THERE WAS NO PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER'S BIOMED EVALUATED THE REPORTED ISSUE AND FOUND THAT THE PINS OF THE COMMAND MODULE WERE BENT AND PUSHED IN. THE BIOMED READJUSTED THE PINS AND CONFIRMED THAT THE ISSUE WAS RESOLVED. THE CAUSE OF THE REPORTED ISSUE WAS DUE TO BENT PINS ON THE COMMAND MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284993 ↗
• MalfunctionSep 2, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT WHILE MONITORING PATIENTS, THE MODULE WOULD INTERMITTENTLY LOSE WAVEFORMS. CLINICAL STAFF WOULD RESET THE MONITOR TO GET VITALS TO RESUME. THE CUSTOMER REPORTED THAT THEY MOVED THE PATIENT TO A NEW PATIENT MONITOR. THE CUSTOMER WAS ADVISED TO REACH OUT TO THEIR INTERNAL BIOMED TEAM TO EVALUATE THE DEVICE. AT THIS TIME, THE CUSTOMER HAS NOT RESPONDED TO ATTEMPTS TO GET ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949025 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103142. One submission often covers many models, so check the product and lot details in each record.

• Z-2247-2026 · Apr 24, 2026 · Open, Classified
  GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patie
• Z-2243-2026 · Apr 24, 2026 · Open, Classified
  GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, P
• Z-2246-2026 · Apr 24, 2026 · Open, Classified
  GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v
• Z-2245-2026 · Apr 24, 2026 · Open, Classified
  GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor,
• Z-2244-2026 · Apr 24, 2026 · Open, Classified
  GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With A
• Z-1503-2023 · Apr 12, 2023 · Open, Classified
  Ultraview SL (UVSL) Command Module, Model 91496
• Z-2343-2016 · Jul 1, 2016 · Terminated
  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,
• Z-1577-2015 · Apr 21, 2015 · Terminated
  Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management S
• Z-1542-2015 · Apr 17, 2015 · Terminated
  Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care M
• Z-1705-2014 · May 8, 2014 · Terminated
  Spacelabs Medical Ultraview SL Command Module, Model 91496. Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to a
• Z-0690-2012 · Nov 3, 2011 · Terminated
  Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various
• Z-0776-2012 · Jul 13, 2011 · Terminated
  Spacelabs Medical Ultraview SL Command Module, Model 91496. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, mon