GentleCool Pro Cryogen Canister (2019-09-09)

Starting date:

September 9, 2019

Posting date:

October 11, 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-71227

Last updated: 2019-12-11

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  Reason
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  Affected products

Affected Products

GentleCool Pro Cryogen Canister

Reason

The issue observed in the field and documented in Candela's associated complaints details that the neck bushing (or top) of the canister becoming disconnected from the body of the canister, causing rapid depressurization. This event can injure the patient/operator by a) uncontrolled cryogen gas spray and b) propelling the gas canister away from the system in an uncontrolled manner with significant velocity. Please refer to the attached health hazard evaluation for a complete description.

Affected products