Z-1395-2018Class II

GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626...

Name: Z-1395-2018 GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626...
Creator: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
Published: 2018-03-16
License: https://open.fda.gov/license/

GE Healthcare / initiated 2018-03-16 / Terminated / root cause: software

FDA source

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL began a recall of GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344... on 2018-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1395-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-16
Posted: 2018-04-17
Terminated: 2020-12-14
Recalling firm: GE Healthcare
Product: GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 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.
Product code: KGI Densitometer, Bone
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.
Root cause tag: software
FDA root cause: Software design
Action: The firm initiated their recall by letter on March 16, 2018. The notice stated: "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. There have been no injuries reported as a result of this issue. You can continue using your system by disabling the DICOM MPPS feature as follows: 1. In enCORE, select Tools | Connectivity Options. 2. Select DICOM tab. 3. Press Configure Connections in DICOM Worklist section. 4. In the MPPS SCP Settings, clear the AE Title and the TCP/IP Address fields 5. Press OK to all. A GE Healthcare representative will contact you to arrange for the correction." For further questions, please call (608) 826-7492
Quantity in commerce: 303 units
Distribution: 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.
Product codes and lots: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1395-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1393-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1394-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1395-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

Product code KGI

K982267Class IIDpx-Rx Bone DensitometerLunar Corp. / cleared 1998-08-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)