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Sensus Healthcare, Inc. Recall: Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module I

Sensus Healthcare, Inc. Recall: Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module I is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Sensus Healthcare, Inc.; Product: Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Ra

Recalling firmSensus Healthcare, Inc.
ProductSensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
Reason for recallWhen the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionUS Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
Recall initiated20230210
Recall numberZ-1235-2023
Categorydevice
StateFL
CountryUnited States

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