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U.S. Department of Health and Human Services

Class 2 Device Recall Pressure Imaging System

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  Class 2 Device Recall Pressure Imaging System see related information
Date Initiated by Firm July 20, 2009
Date Posted January 18, 2011
Recall Status1 Terminated 3 on January 31, 2011
Recall Number Z-0919-2011
Recall Event ID 54229
Product Classification System, pressure measurement, intermittent - Product Code JFC
Product 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 pressure mapping systems, are a valuable tool in helping clinicians prevent and manage pressure ulcers. Clinicians, nurses, and rehabilitation specialists use XSENSOR pressure imaging systems to help prevent pressure ulcers through improved surface selection and patient positioning on wheelchairs and hospital beds.
Code Information Serial numbers for X3 display: CTDPDA00 S2000 R04, CTDPDA00 S2001 R04, CTDPDA00 S2002 R04, CTDPDA00 S2003 R04, CTDPDA00 S2004 R04, CTDPDA00 S2005 R04, CTDPDA00 S2006 R04, CTDPDA00 S2007 R04, CTDPDA00 S2013 R04, CTDPDA00 S2016 R04, CTDPDA00 S2017 R04, CTDPDA00 S2021 R04, CTDPDA00 S2022 R04, CTDPDA00 S2024 R04, CTDPDA00 S2025 R04, CTDPDA00 S2026 R04, CTDPDA00 S2027 R04, CTDPDA00 S2028 R04, CTDPDA00 S2030 R04, CTDPDA00 S2032 R04, CTDPDA00 S2035 R05, CTDPDA00 S2036 R05, CTDPDA00 S2037 R05, CTDPDA00 S2038 R05, CTDPDA00 S2039 R05, CTDPDA00 S2040 R05, CTDPDA00 S2041 R05, CTDPDA00 S2042 R05, CTDPDA00 S2043 R05, CTDPDA00 S2044 R05, CTDPDA00 S2045 R05, CTDPDA00 S2050 R05, and CTDPDA00 S2054 R05.   Serial numbers for X3 PRO: CMUHUB00 S2023 R05 and CMUHUB00 S2033 R05.   
Recalling Firm/
Xsensor Technology Corporation
111 319 2nd Ave Sw
Calgary Canada
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Component change control
Action 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.
Quantity in Commerce 33 units of X3 Display and 2 units of X3 Pro
Distribution Devices were distributed to one distributor, medical facilities, and rehab centers through out the US, including following states: AL, AR, AZ, CA, CO, FL, GA, IA, IL, KS, ME, MI, MN, MO, NC, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, and WI.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.