Device Recall Nuclear Gamma Cameras 의 리콜

Recall

67901

Class 2

Z-1510-2014

2014-03-10

2014-04-26

Terminated

United States

2015-08-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126583

Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.

On 03/10/2014, the firm sent Urgent - Medical Device Correction letters to their customers. The letter identified the affected product, the reason for recall, the hazard involved, and the actions that should be taken by customers. Customers are to cease use of the identified procedures until implementation of the Field Change Order. Additionally, customers should sign and return the attached Customer Response Form within 10 days of receipt, acknowledging that they have read and understood the Field Safety Notice and Addendum. The Field Safety Notice must be placed in customers' User Documentation. Customers are to contact their local Philips Healthcare representative or office, if they need further information or support.