—#130747

Product

Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA product code: IZI — System, X-Ray, Angiographic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K073290
Affected lot / code info: model number 10280959, with serial numbers 1000-1599

Why it was recalled

A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness.

Root cause (FDA determination)

Device Design

Action the firm took

Siemens sent an " Important Safety Information " letter dated September 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Siemens will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. Our service organization will contact with you to schedule an appointment to perform the corrective action. Please feel free to contact our service organization for an earlier appointment. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. For further questions, please call (610) 219-6300.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: Nationwide Distribution including Puerto Rico.

Timeline

Recall initiated: 2014-09-23
Posted by FDA: 2014-11-07
Terminated: 2017-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.