Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Clev

FDA device recall Z-1510-2014 · posted 2014-04-26 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KPS

Quantity affected

1,043 cameras

Distribution

Worldwide Distribution -- USA, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Ireland, Italy, Korea, Lebanon, Malaysia, Netherland

Date initiated

2014-03-10

Date posted

2014-04-26

Date terminated

2015-08-04

Location

Cleveland, OH

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