Retiro De Equipo (Recall) de Examiner 3DX 6000 StandAlone & InLine Systems

Recall

78658

Class 2

Z-0270-2018

2017-10-27

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160074

L3 has determined in airport environments, there have been several cases where a small air gap has developed where the entrance or exit tunnels meet up with the main x-ray scanner tunnel. this a gap in x-ray shielding can result in x-ray emissions that exceed the limit in the federal performance standard for cabinet x-ray systems (see 21 cfr ¿ 1020.40(c)(1)).

L3 Security & Detection Systems will bring defect into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 244 of the 471 installed units will consist of the following: 1. L3 completed an investigation of the status of all 471 potentially affected units on October 15, 2017 and determined that tunnel separation events were possible for 244 units. Of these 244 units, 120 of the units did not have a separation kit installed and 124 of the units had separation kits which required repair. 2. The 120 units that are missing the tunnel separation kits (components designed to prevent tunnels from separating from the main x-ray scanner) will have new kits installed. 3. An additional 124 units had tunnel separation kits installed but had suffered damage or wear and tear not covered by prior maintenance schedules which rendered the kits ineffective. The existing tunnel separation kit components on the affected systems will be repaired or replaced as necessary. 4. Each 3DX system tunnel kit will be inspected a minimum of every 38 days to ensure proper fit and function to ensure that none of the hardware has loosened from the fixtures. The procedure for inspecting the tunnel kits is provided to L3 field technicians in the Maintenance and Service Manual. L3 is the only authorized service provider for the 3DX 6000 series and TSA relies upon L3 to perform all servicing of the units. 5. The schedule of maintenance required to assure continued compliance with the performance standard has been updated to include periodic inspection of separation kits. This updated schedule of maintenance has been provided to TSA. 6. All repair materials, the tunnel separation kits, will be supplied by L3 and installed by the L3 field technician at no cost to the TSA (the units owner). 7. The corrections are expected to be completed by April 30, 2018; however, completion is subject to approval by TSA for the ECO for the correct