Health product recall

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

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

Apollo - Main Unit

Lot or serial number

s/n 08070501

Model or catalog number
  • 9784120231
Companies
Manufacturer

Villa Sistemi Medicali S.P.A.

via Delle Azalee 3

Buccinasco

20090

ITALY