Dec

1998

Picker International 4 recalls

Four Recalls of Picker International Nuclear Cameras and imaging systems12/15/98 Prism XPVT 63 units. Unexpected camera movement which requires the operator to power down and reboot with delay in diagnosis. Z-643/650-9
11/18/98 Model 3000 325 units. Unintended motion of gantry during setup. Z-641/642-9

11/17/98 ModelFX AND fx 800 WITH VERSION 8.3.11 software. 70 units. Software error may result in patient misdiagnosis. Z-655/656-9

5/12/97 Prism 158 units. Software rror may result in loss of data requiring patient re-scan and possible delay in diagnosis. Z-651/654-9

2/19/97 Prism 70 units. Incorrect head movement and message display due to software errors. Z-658/659-9

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Picker International 4 recalls

Amy Sellers

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