Z-0919-2011

Product labeling of the X3 Display reads in part: "XSENSOR Technology CorporationX3 DISPLAY REF...

Name: Z-0919-2011 Product labeling of the X3 Display reads in part: "XSENSOR Technology Corporation***X3 DISPLAY*** REF...
Creator: Xsensor Technology Corporation
Published: 2009-07-20
License: https://open.fda.gov/license/

Xsensor Technology Corp. / initiated 2009-07-20 / Terminated

FDA source

Xsensor Technology Corporation began a recall of Product labeling of the X3 Display reads in part: "XSENSOR Technology Corporation***X3 DISPLAY*** REF: XBOM-002 PID: CTDPDA00 S*** R***60601-1... on 2009-07-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0919-2011
Status: Terminated
Initiated: 2009-07-20
Posted: 2011-01-18
Terminated: 2011-01-31
Recalling firm: Xsensor Technology Corp.
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.
Product code: JFC System, Pressure Measurement, Intermittent
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 root cause: 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.
Product codes and lots: 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.

Product code JFC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)