Health product recall

SENTINEL V10 CARDIOLOGY INFORMATION MANAGEMENT SYSTEM & SENTINEL V11 (2020-11-17)

Starting date:
November 17, 2020
Posting date:
November 27, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74435

Last updated:
2020-11-27

Affected Products

A. SENTINEL V10 CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

B. SENTINEL V11

Reason

Spacelabs has received a report of incorrect comments in sentinel files after upgrading from version 9.

Affected products

A. SENTINEL V10 CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

98200

Companies
Manufacturer

Spacelabs Healthcare Inc.

35301 SE Center Street

Snoqualmie

98065

Washington

UNITED STATES

B. SENTINEL V11

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

98201

Companies
Manufacturer

Spacelabs Healthcare Inc.

35301 SE Center Street

Snoqualmie

98065

Washington

UNITED STATES