Spacelabs Healthcare, Ltd. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product DesClass IISep 16, 2025Due to two distinct issues: 1. During patient admission, pa	Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of	Class IIDevices	Sep 16, 2025
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patClass IINov 25, 2024Due to a manufacturing error the incorrect device serial num	Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter rec	Class IIDevices	Nov 25, 2024
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recordClass IINov 25, 2024Due to a manufacturing error the incorrect device serial num	Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter rec	Class IIDevices	Nov 25, 2024