Philips Xcelera and Intellispace Cardiovascular (ISCV) (2018-05-08)

Starting date:

May 8, 2018

Posting date:

June 1, 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-66922

• 
  Reason
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  Affected products

Affected products

A. Xcelera

B. Intellispace Cardiovascular

Reason

Philips has become aware that a non-validated 3rd party software application (influx workflow solutions) has been sold by Philips Canada as an add-on to three (3) Philips Xcelera and Intellispace Cardiovascular (ISCV) customers in Canada. This 3rd party influx software application had not been validated by the Philips OEM for integration and compatibility with our Xcelera and ISCV systems prior to sale. Upon becoming aware of this, the Philips OEM started to analyze the software's configuration with the aim to remediate this situation and with the intent to validate the influx workflow solution and allow further sale of the influx 3rd party software integration. This validation procedure did not prove successful, however, and the Philips OEM has decided not to pursue any further validation or certification of the influx workflow solution. Accordingly, Philips Canada is now issuing this recall in order to ensure that the three (3) Philips Xcelera and ISCV affected installed base are informed of the effect of the non-validated 3rd party add on their ongoing support, service and maintenance. Analysis of the influx integration does not indicate that the use of Xcelera / ISCV according to their intended use has been compromised, nor has any hazard or possible source of harm been identified.

Affected products