CAPTUS 4000e (2020-03-02)

Starting date:

March 12, 2020

Posting date:

May 1, 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-72919

Last updated: 2020-05-01

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  Reason
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  Affected products

Affected Products

CAPTUS 4000e

Reason

Manufacturer received two notices of collimator detachment from Captus 4000 systems shipped in July and September of 2016.  The collimator weighs 28 pounds and may cause injury if it falls on a patient or operator.  Safety inspection and possible recall includes serial numbers 940103 through 940155.

Affected products