Site~Rite 8 Ultrasound System (2019-11-13)

Starting date:

November 13, 2019

Posting date:

December 6, 2019

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-71812

Last updated: 2019-12-06

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  Reason
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  Affected products

Affected Products

Site~Rite 8 Ultrasound System

Reason

BD has become aware of an issue affecting the Battery Status Indicator on Site~Rite 8 Ultrasound Systems. The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8 has the potential to abruptly shut down, without advance warning to the user, when running on battery power only. This issue will not occur when the unit is plugged into an AC power source, as specified in the Instructions for Use

Affected products