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Terminated

Advantx 1 SC Model 36006617 Angiographic X-ray System

FDA Recall Z-0900-04 · Posted 2004-07-20

Recalling FirmGeneral Electric Med Systems
Recall StatusTerminated
Product CodeIZI
Date Initiated2004-03-24
Date Terminated2006-07-24

Reason for Recall

Unintended movements of both the C-arc and the image intensifier have occured due to shearing of the gear motor shaft as a result of the misalignment of the gearbox.

Firm Action

Field modification instructions were issued on 3/24/04 to GE field engineers who are to correct the devices at hospitals. No letter about the correction was sent to the hospitals.

Root Cause

Other

Distribution Pattern

The units were distributed nationwide in the United States and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K890348LC, CARDIAC POSITIONER #B5078AGeneral Electric Co. · 1989-02-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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