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Terminated

Sensus 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

FDA Recall Z-1235-2023 · Posted 2023-03-08

Recalling FirmSensus Healthcare, Inc.
Recall StatusTerminated
Product CodeJAD
Date Initiated2023-02-10
Date Terminated2024-01-31
Product Quantity23 units

Reason for Recall

When 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.

Firm Action

Sensus healthcare issued an "Urgent Device Correction" to its consignees on 02/10/2023 by email. The notice requested the following actions: "Do not initiate beam delivery after a pause & resume sequence without verifying the amount of dose delivered. Do evaluate any patient treatments with version 1.9.2 that followed the pause & resume workflow. Do verify that the amount of dose to be delivered is as expected after each pause & resume sequence." The firm has developed a permanent software resolution for this issue. Customer service will contact the customer to coordinate upgrading to this revised software. Questions: Contact Sensus Customer Support at [email protected] or 561-578-4982

Root Cause

Software design

Distribution Pattern

US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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