Health product recall

Alice 6 PSG System (2018-03-16)

Starting date:
March 16, 2018
Posting date:
May 11, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66726

Affected products

Alice 6 PSG System

Reason

Philips Respironics has identified an issue with the amount of memory installed in the PC provided for use with Sleepware G3 and the Alice 6 PSG system. Impacted PCs are configured with 4GB of installed memory (RAM) instead of the recommended and documented 8GB. The lower amount of RAM can impact the performance of Sleepware G3 software, but will not render the software inoperable or impact the ability to conduct studies or collect data. Installation of a 4GB DIMM card, which will be provided by Philips Respironics, is required to upgrade the system to the intended 8GB configuration.

Affected products

Alice 6 PSG System

Lot or serial number

Not applicable

Model or catalog number

Not applicable

Companies
Manufacturer

Respironics Inc.

1001 Murray Ridge Lane

Murraysville

15668

Pennsylvania

UNITED STATES