Retiro De Equipo (Recall) de Device Recall EOS System X ray beam

Recall

66833

Class 2

Z-0529-2014

2013-11-07

2014-01-09

Terminated

United States

2015-01-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123687

Eos imaging discovered during production internal testing that the x-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the x-ray beam operated by the eos system during the x-ray acquisition.

CDRH approves the following conditions for EOS Imaging SA: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator notes below what are to be included in the notification. The draft letter provided on November 28, 2013, is deficient for the following reasons: a. It does not provide a statement that all repairs will be made without charge (21 CFR 1003.21(3)). b. It does not provide instructions, with respect to the use of the product pending the correction of the defect (21 CFR 1003.21(1). Specifically, the letter should include directions for the user to determine if the collimation defect is currently present in their system, which would initiate immediate correction, rather than at the next semi-annual service. 2. The customer notification letter will be sent in the manner required by 21 CFR 1003.21(b). 3. The repairs outlined are to be completed by July 1, 2014. All systems under service contracts (which includes semi-annual service) would be visited between receipt of this letter and July 1, 2014. All repairs, including those to systems which are not under service contracts, are also expected to be completed by July 1, 2014. EOS may proceed with implementation of the CAP (subject to the conditions noted above. The customer notification letter may be sent out immediately upon addressing the above deficiencies. However, it is suggested that you provide a copy of the revised letter to FDA for approval prior to issuance. For further questions please call (678) 564-5400.