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.
Reported: May 7, 2014 Initiated: March 10, 2014 #Z-1510-2014
Product Description
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.
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units 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, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, Spain, Sweden, Thailand, & United Kingdom.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 1,043 cameras.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 7, 2014. Severity: Moderate. Recall number: Z-1510-2014.
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