Device Recall Pressure Imaging System

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.

Physical Medicine Devices

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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.

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.