Spacelabs Healthcare, Inc.
10 federal recalls on file, showing the 5 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Spacelabs Healthcare, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-15FDA-DeviceClass IIContact Spacelabs about your Model 91496 monitor
Certain Spacelabs Healthcare Model 91496 multi-parameter cardiac monitors have a circuit board defect. When the device is in Auto mode, the cardiac output measurement may start too early, causing errors that prevent proper readings or exclude readings that should be included. This could lead to inaccurate patient information and delayed medical decisions.
- 2025-11-12FDA-DeviceClass IIBrand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardiology Information Management System is intended to connect to supported medical devices and analyzers in order to download, store, access and manage cardiovascular information and to manage patient and facility information.
Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record
- 2025-10-22FDA-DeviceClass IIBrand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
- 2025-10-22FDA-DeviceClass IIBrand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
- 2025-10-22FDA-DeviceClass IIBrand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
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