Recall Z-0216-2020— Philips Medical Systems (Cleveland) Inc
Class I · Terminated
Class I FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2019-09-19, terminated 2021-04-05. It names one FDA 510(k) clearance: K982911. Product: 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: 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..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-09-19
- Terminated
- 2021-04-05
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.