Recall Z-2052-2026 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Inc.
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configura
| Date | May 1, 2026 (initiated Mar 26, 2026) |
| Status | Open, Classified |
| Reason | Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester). |
| Root cause | Process control |
| Action | On 03/26/2026, the firm sent via email an URGENT MEDICAL DEVICE CORRECTION Letter to customers informing them that Spacelabs Healthcare became aware that for certain Multi-Parameter Command Modules (Model 91496) manufactured between 07/17/2025 to 08/05/2026 using a malfunctioning test equipment resulting in inadequate electrical leakage testing. Customers are instructed to: 1.Notify Please notify all relevant employees within your organization, including facilities you have distributed the products to, of this medical device correction notice and to cease use of the modules identified in Ap |
| Quantity | 57 |
| Distribution | Worldwide - US Nationwide di GA, KS, MI, OH, SC, TX, WA and the country of ARGENTINA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103142 | SPACELABS MULTI-PARAMETER MODULE Spacelabs Healthcare, Inc., Mar 3, 2011 |