GE Inspection Technologies, LP
Lewistown, PA, US
GE Inspection Technologies, LP appears in FDA device records in Lewistown, PA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 12 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 12
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0442-2021 | v|tome|x L Series non-destructive testing cabinet x-ray systems | It was discovered during testing of the v/tome/x L450 system s/n PA1790, that the pre-warning signals does not provide "Audible and visible warning signals within the cabinet" if the "warm up" mode was not completed after initializing the system when first turned on. | Class II | Terminated | |
| Z-2777-2017 | GE Inspection Technologies Blade|line Industrial Cabinet X-ray system | GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one hour (21 CFR 1020.40(c)(1)(i)) underneath the bottom center of the system. The crawl space affected by the excess emission is approximately 22 inches high, normally covered by decorative panels, and is not intended to be accessed. | Class II | Terminated | |
| Z-2236-2016 | GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for 3D metrology and analysis. | Radiation emissions which exceeded the limit in the performance standard were detected during maintenance of one system. The identified cause was insufficient attachment of shielding in the door. Jostling during delivery was identified as the probable cause of this failure to comply with the performance standard. | Class II | Terminated | |
| Z-1231-2016 | GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control. | GE Inspection Technologies, LP ("GE") has discovered that certain of its cabinet x-ray systems may not fully comply with the Food and Drug Administration's (FDA) Cabinet X ray System performance standards, 21 C.F.R. 1020.40(c)(1)(i) | Class II | Terminated | |
| Z-1225-2015 | GE Inspection Technologies x|argos 160D system. Cabinet x-ray system. | It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding. | Class II | Terminated | |
| Z-1211-2015 | GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system | It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x L240 installed had lost adhesion and fall out of position, which could lead to gaps in shielding. | Class II | Terminated | |
| Z-2320-2015 | GE Optional Laser Centering Device X-ray generator. | GE has identified a potential failure to comply with 21 C.F.R. 1040.10 and 21 C.F.R. 1010.2 for the alignment laser centering device. | Class II | Terminated | |
| Z-0426-2015 | GE Cabinet X-ray systems | GE discovered these cabinet x-ray systems' potential failure to comply with the Cabinet X-ray System performance standards. | Class II | Terminated | |
| Z-1828-2011 | Phoenix x/ray nanotom series. Phoenix x|ray nanotom series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. | Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed. | Terminated | ||
| Z-1827-2011 | Phoenix x/ray v/tome/x series. Phoenix x|ray v|tome|x series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. | Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed. Two of the systems also lack the sign indicating the meaning of the warning signals. | Terminated | ||
| Z-1826-2011 | Phoenix x/ray inspector series. Phoenix x|ray inspector series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. | Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed. | Terminated | ||
| Z-1825-2011 | Phoenix x/ray analyser series. Phoenix x|ray analyser series cabinet x-ray systems are used in non-destructive testing, failure analysis, process control, and metrology. | Some of the systems do not have a safety interlock on the service access panel. Although the systems have two independent means for indicating when x-rays are being generated, some systems may have one indicator that is not discernible. Also, some systems lack proper placement of a caution label and others do not have this label affixed. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain