Apollo - Main Unit (2019-10-30)

Starting date:

October 30, 2019

Posting date:

November 15, 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-71615

Last updated: 2019-11-15

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  Reason
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  Affected products

Affected Products

Apollo - Main Unit

Reason

Following information received from field, it was found that the number of tilting cycles for some units used in high-workload environments had to be increased with respect to the initial specifications. After laboratory testing of the current angulation chain, it was found that it is very close to the design limit for metal fatigue and, under severe workload conditions might fail before the expected lifetime of 10 years.

Affected products