Spectra Optia Apheresis (2019-05-21)

Starting date:

May 21, 2019

Posting date:

June 14, 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-70205

Last updated: 2019-06-14

• 
  Reason
• 
  Affected products

Affected Products

Spectra Optia Apheresis

Reason

A connection problem to the closed circuit card assembly (CCA) of the Gen2 ebox (component of the Spectra Optia Apheresis System) was discovered. The connection issue potentially affects multiple equipment operations which may impact a planned or ongoing treatment procedures. Investigation showed that a CCA was not seated properly on it's physical supports (pems) due to the pems being various heights. This variation allows for potential bowing of the CCA,thus causing connection issues.

Affected products