Recall Z-1503-2023— Spacelabs Healthcare, Inc.

Name: FDA recall Z-1503-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-12

Class II · Ongoing

Class II FDA medical device recall by Spacelabs Healthcare, Inc., initiated 2023-04-12. It names one FDA 510(k) clearance: K103142. Product: Ultraview SL (UVSL) Command Module, Model 91496. Reason: 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..

Recalling firm: Spacelabs Healthcare, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-12
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K103142 — SPACELABS MULTI-PARAMETER MODULESpacelabs Healthcare, Inc.·cleared 2011-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.