GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand; Overhead tube suspension; operator console and digital archive system.
FDA Recall Z-1304-06 · Posted 2006-09-22
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Recalling FirmGeneral Electric Med Systems LLC
Recall StatusTerminated
Product CodeJAA
Date Initiated2006-05-15
Date Terminated2007-05-25
Product Quantity1,289
Reason for Recall
Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam
Firm Action
An Important Notice for Precision 500D, dated 11/24/2005 was hand delivered to all customers beginning 05/15/06, by GE field service engineers at the time they were to perform the correction to the device.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Puerto Rico, Canada, France, Germany, Indonesia, Italy, Japan, Jordan, Kuwait, Macedonia, Panama, Russia, Saudi Arabia, Singapore, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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