GE OEC Medical Systems, Inc: OEC Elite Systems with 9-inch Image Intensifier

Hazard

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

Details from the source

Reason for recall: Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Quantity: 812 Lot/code info: UDI-DI: 00840682121729 Serial Numbers: FSXXTX00180, FSXXXX00020, F9XXTX00007, F9XXTX00008, F9XXXX00021, FSXXTX00068, FSXXTX00303, FSXXXX00054, FSXXTX00333, FSXXTX00272, F9XXXX00046, FSXXXX00009, FSXXXX00005, FSXXTX00350, F9XXTX00025, FSXXTX00131, FSXXTX00103, FSXXTX00116, FSXXTX00073, FSXXXX00056, FSXXTX00120, FSXXTX00171, FSXXTX00307, FSXXXX00006, FSXXTX00153, FSXXTX00154, FSXXTX00214, FSXXTX00048, FSXXTX00062, FSXXTX00170, FSXXTX00172, FSXXTX00362, FSXXTX00368, FSXXXX00024, F9XXTX00202, FSXXTX00326, FSXXTX00260, FSXXTX00133, FSXXXX00011, FSXXTX00286, F9XXTX00045, FSXXTX00241, FSXXTX00179, FSXXTX00276, FSXXTX00396, FSXXTX00034, FSXXTX00359, FSXXTX00248, FSXXXX00057, FSXXTX00079, FSXXTX00274, FSXXXX00032, FSXXTX00331, FSXXTX00042, FSXXTX00114, FSXXXX00007, FSXXTX00345, FSXXTX00065, FSXXTX00173, FSXXTX00191, FSXXTX00123, FSXXTX00376, F9XXTX00238, FSXXTX00234, FSXXTX00107, FSXXTX00298, F9XXXX00050, FSXXXX00036, FSXXXX00039, FSXXTX00373, FSXXTX00338, FSXXTX00382, FSXXTX00045, FSXXTX00118, F9XXTX00155, F9XXTX00179, FSXXTX00305, F9XXTX00053, FSXXTX00119, FSXXTX00135, FSXXTX00136, FSXXTX00221, FSXXXX00063, FSXXTX00067, FSXXTX00244, FSXXXX00062, FSXXTX00060, F9XXTX00059, FSXXTX00204, F9XXTX00040, FSXXTX00036, FSXXTX00099, F9XXTX00149, F9XXXX00013, F9XXXX00028, F9XXTX00019, FSXXTX00327, F9XXTX00017, F9XXTX00018, FSXXTX00216, FSXXTX00414, FSXXTX00315, FSXXTX00209, F9XXTX00121, F9XXTX00153, FSXXTX00027, FSXXTX00158, FSXXTX00231, FSXXTX00405, FSXXTX00406, FSXXTX00072, F9XXTX00030, FSXXT

UPC codes

00840682121729

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.