—#179454

Product

Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173639
Affected lot / code info: Serial numbers 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962

Why it was recalled

Siemens became aware of an issue of incorrect use of the bypass key overriding the built-in collision control creating risk of collision with obstacles or persons when the operator uses the override function.

Root cause (FDA determination)

Use error

Action the firm took

On January 8, 2020, the firm initiated the recall, notifying customers via Urgent Medical Device Correction letters. Customers were advised of the potential for a system collision due to incorrect use of the bypass key overriding the built-in collision control. The bypass key is intended to enable movement of an otherwise blocked system to avert immediate hazard, e.g. to recover a patient following device error or in case of emergency. It is not intended for permanent use. Customers were instructed to use the bypass key exclusively to avert an immediate hazard and immediately contact Siemens Customer Service at 1-800-888-7436 to fix the issue. Siemens Healthineers will correct the error with a field software update which will be available starting in January 2020, free of charge. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action when the software update is available for your system. Customers may contact the firm's service organization for an earlier appointment at 1-800-888-7436. With this field software update, an additional acoustic signal will be introduced for an event of movement in an error situation. The signal alerts the user that the system is in the "override" state and special attention should be paid regarding possible collisions. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-01-08
Terminated: 2022-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179454. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.