Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Reported: November 13, 2019 Initiated: September 19, 2019 #Z-0217-2020
Product Description
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.
Reason for Recall
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 1167 in total
- Distribution
- Nationwide Distribution.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personnel.. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: 1167 in total.
Why was this product recalled? ▼
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Critical. Recall number: Z-0217-2020.
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