FDA Device recall Z-1503-2023
Ultraview SL (UVSL) Command Module, Model 91496
- FDA Device
- Class II
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of Ultraview SL (UVSL) Command Module, Model 91496 by Spacelabs Healthcare, citing 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)….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1503-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-12 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Spacelabs Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | Software version 2.03.06 and earlier and software version 2.04 and later. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1503-2023%22
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