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Z-1394-2018 Class II Terminated

Recalled by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL — Madison, WI

FDA device recall Z-1394-2018 was initiated by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL on March 16, 2018 and is designated Class II. Reason for recall: Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct … The recall status is terminated (terminated December 14, 2020). Affected quantity: 43 units.

Recall Details

Product Type: Devices
Report Date: April 25, 2018
Initiation Date: March 16, 2018
Termination Date: December 14, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 43 units

Product Description

GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.

Reason for Recall

Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Malta, Mexico, Morocco, Norway, Poland, Portugal , Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab, United Kingdom and Venezuela.

Code Information

a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352

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