Marconi MINICAP workstations Class II

PRODUCT

MINICAP XP Workstations, using Baseline 8.5 software, for Computed
Tomography SPECT studies with gamma cameras.

Recall #Z-515-0.

REASON

During 360 degree SPECT, the resulting image will appear
flipped left to right.

CODE

All Marconi MINICAP XP workstations using the Baseline 8.5
software.

MANUFACTURER

Marconi Medical Systems, Inc., Highland Heights, Ohio.

RECALLED BY

Manufacturer, by letter dated February 28, 2000.
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

131 units were distributed.

About the author

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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.