Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography syste

FDA device recall Z-0183-2015 · posted 2014-11-07 · Terminated

Recall details

Recalling firm

Siemens Medical Solutions USA, Inc

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

IZI

Quantity affected

164

Distribution

Nationwide Distribution including Puerto Rico.

Date initiated

2014-09-23

Date posted

2014-11-07

Date terminated

2017-05-08

Location

Malvern, PA

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