SEDECAL SA: Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500

Hazard

Due to un-commanded movement of mobile x-ray unit.

Details from the source

Reason for recall: Due to un-commanded movement of mobile x-ray unit. Distribution: U.S.: KY, WI, FL, DE, WV, CA, MO, NY, NC, AL, AR, MS, GA, IL, IA, TN, KS, KY, IN, HI, OH, WY, PA, NV, RI, UT, AZ, OK, MN, ME, MT, WA, VA, SD, MI, LA, and TX O.U.S.: N/A Quantity: 155 systems Lot/code info: Model: Soltus 450 Type / UDI-DI Code: 10451 /08436046002555 10451-1 / 08436046002562 10451-2 / 08436046002531 10451-3 / 08436046002548 Serial Numbers / UDI Codes: SLS000014 (01)08436046002555(240)10451(11)200700(21)SLS000014 SLS000038 (01)08436046002555(240)10451(11)200800(21)SLS000038 SLS000039 (01)08436046002555(240)10451(11)200800(21)SLS000039 SLS000040 (01)08436046002555(240)10451(11)200900(21)SLS000040 SLS000046 (01)08436046002555(240)10451(11)200900(21)SLS000046 SLS000048 (01)08436046002555(240)10451(11)201000(21)SLS000048 SLS000050 (01)08436046002555(240)10451(11)201000(21)SLS000050 SLS000051 (01)08436046002555(240)10451(11)201000(21)SLS000051 SLS000077 (01)08436046002555(240)10451(11)201100(21)SLS000077 SLS000078 (01)08436046002555(240)10451(11)201000(21)SLS000078 SLS000079 (01)08436046002555(240)10451(11)201100(21)SLS000079 SLS000080 (01)08436046002555(240)10451(11)201100(21)SLS000080 SLS000081 (01)08436046002555(240)10451(11)201100(21)SLS000081 SLS000082 (01)08436046002555(240)10451(11)201100(21)SLS000082 SLS000083 (01)08436046002555(240)10451(11)201100(21)SLS000083 SLS000084 (01)08436046002555(240)10451(11)201100(21)SLS000084 SLS000085 (01)08436046002555(240)10451(11)201100(21)SLS000085 SLS000086 (01)08436046002555(240)10451(11)201100(21)SLS000086 SLS000087 (01)08436046002555(240)10451(11)201100(21)SLS000087 SLS000088 (01)08436046002555(240)10451(11)201100(21)SLS000088 SLS000089 (01)08436046002555(240)10451(11)201100(21)SLS000089 SLS000090 (01)08436046002555(240)10

UPC codes

08436046002555, 08436046002562, 08436046002531, 08436046002548, 08436046002456, 08436046002463, 08436046002432, 08436046002449

Source

Official record: FDA (Device enforcement) ↗

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