ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100

FDA device recall Z-0523-2024 · posted 2023-12-09 · Open, Classified

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.

Action taken

On October 17, 2023, the firm issued an URGENT MEDICAL DEVICE CORRECTION letter to affected customers. According to the firm's letter, as the unintended behavior is caused by thermal startup effects, its occurrence can be avoided by only switching off the system for a short time. The firm suggests keeping the system running (except during proposed weekly reboot) if availability for treatment of emergency patients is necessary. Please plan for up to half an hour warm-up time after switching on the system. The firm will contact affected customers to modify the mounting of the tube cover to mitigate the probability of occurrence of the issue. You may contact the firm's service organization for an earlier appointment at 1-800-888-7436.

Root cause

Component design/selection

Status

Open, Classified

Product code

OWB

Quantity affected

38 worldwide, 11 US

Distribution

US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United

Date initiated

2023-10-17

Date posted

2023-12-09

Location

Malvern, PA

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