Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile 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.
Recall
- Recall Number
- Z-1332-2020
- Event Number
- 84813
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- OWB
- Status
- Terminated
- Root Cause
- Use error
- Initiated
- January 8, 2020
- Terminated
- June 21, 2022
- Address
- 40 Liberty Blvd, Malvern, PA, 19355-1418
Description
Luminos Agile Max, Model No. 10762472 - Product Usage: Luminos Agile 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.
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.
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.
US Nationwide distribution.
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