Recall Z-1510-2014 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
| Date | Apr 26, 2014 (initiated Mar 10, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 Docu |
| Quantity | 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, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, Spain, Sweden, Thailand, & United Kingdom. |
| FDA record | Open on fda.gov |