Device recall: GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
Class II FDA enforcement event 77756. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standard’s 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…
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
GE Inspection Technologies, LP started this device recall on 28 Jun 2017. The firm address in the FDA record is in Lewistown, PA. FDA put the recall in Class II. FDA event 77756 has 1 product record. The first FDA enforcement report date is 9 Aug 2017. The record gives the status Terminated, with the termination date 6 Feb 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
Recalling firm
GE Inspection Technologies, LP, Lewistown, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: FDA Mandated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2777-2017 | GE Inspection Technologies Blade|line Industrial Cabinet X-ray system | 13 units distributed in the US | Class II | Terminated | 9 Aug 2017 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Mar 2016 | GE Inspection Technologies, LP - Phoenix v|tome|x m240 cabinet x-ray systems. A microfocus CT system used primarily for | Device | Class II | 1 |
| 16 Dec 2015 | GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control. | Device | Class II | 1 |
| 13 Jan 2015 | GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system | Device | Class II | 2 |
| 10 Nov 2014 | GE Optional Laser Centering Device X-ray generator. | Device | Class II | 1 |
| 10 Nov 2014 | GE Cabinet X-ray systems | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-2777-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 77756. https://recallregister.com/fda/ii/77756/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Distribution to the states of : AL, SC, OH, MI, PA, and Internationally to Germany and Singapore
- What quantity of product is in FDA event 77756?
- The FDA record gives this quantity:
13 units distributed in the US
- How did the recall start?
- The FDA record says:
FDA Mandated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.