FDA
Product labeling of the X3 Display reads in part:
"XSENSOR Technology Corporation***X3 DISPLAY*** REF: XBOM-002 PID: CTDPDA00 S*** R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada".
Product labeling of the X3 PRO reads in part:
"XSENSOR Technology Corporation***X3 PRO***REF:XBOM-004 PID: CMUHUB00 S***R***60601-1 61010-1***Calgary, AB, CANADA***Made in Canada".
Pressure mapping and surface assessment for seats, seat backs, and beds. XSENSOR pressure imaging systems, also known as pres
The plastic enclosures for the X3 Display and X3 PRO Pressure Mapping System has a UL94 HB flammability rating while the medical equipment specification UL 60601-1 requires V-2 rated plastic for electronic enclosures.
On July 6, 2009, Xsensor sent an "URGENT: MEDICAL DEVICE RECALL" notifications to their consignees/customers.
The consignees/customers were informed that the incorrect material of the plastic enclosures was used. The incorrect plastic had a UL94 HB flammability rating while the medical equipment specification UL 60601-1 required V-2 rated plastic for electronic enclosures.
The firm provided prepaid shipping box to consignees/customers with instructions for returning the components. The components were refurbished and returned to consignees for free of charge.
For further information please contact XSENSORs Customer Support at 1-866-927-5222.