Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000

FDA device recall Z-1294-2022 · posted 2022-06-27 · Open, Classified

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.

Action taken

Firm notified customers of the recall on June 10, 2022 via Urgent Medical Device Correction letters. The firm strongly recommends reinforcing appropriate emergency procedures until the corrective action has been performed. Please ensure that patient treatment can be continued in other ways if there is any possible danger to the safety of the patient. The firm will exchange the affected video transmission links. Their service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact the firm's service organization for an earlier appointment at 1-800-888-7436. The firm does not consider it necessary to re-examine any patients previously treated using the Artis pheno system.

Root cause

Process control

Status

Open, Classified

Product code

JAA

Quantity affected

136 systems

Distribution

Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco

Date initiated

2022-06-10

Date posted

2022-06-27

Location

Malvern, PA

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