CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report

GE Healthcare Lunar: a) DPX NT recalled by GE Medical Systems Ultrasound

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL is recalling GE Healthcare Lunar: a) DPX NT, distributed nationwide in the US. The recall was initiated on 16 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352

Quantity recalled43 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1394-2018
FDA event ID: 79710
Recalling firm: GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, Madison, WI
Classification: Class II
Status: Terminated
Recall initiated: 16 Mar 2018
FDA classified: 17 Apr 2018
Reported: 25 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

16 Mar 2018	Recall initiated by company
17 Apr 2018	Classified by FDA	+32 days
25 Apr 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 79710

Reported	Class	Recall	Company	Reason	Where
25 Apr 2018	CLASS II	GE Healthcare Lunar: a) DPX Duo recalled	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Other	Nationwide
25 Apr 2018	CLASS II	GE Healthcare: a) Prodigy recalled by GE Medical Systems Ultrasound	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Other	Nationwide

More recalls from GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

All 12

Reported	Class	Recall	Company	Reason	Where
12 Sep 2018Device	CLASS II	GE Logiq 9 ultrasound system recalled by GE Medical Systems Ultrasound	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide
12 Sep 2018Device	CLASS II	GE Vivid E9 ultrasound system recalled by GE Medical Systems Ultrasound	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide
12 Sep 2018Device	CLASS II	GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 recalled	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide
12 Sep 2018Device	CLASS II	GE Vivid 7 ultrasound system recalled by GE Medical Systems Ultrasound	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide
12 Sep 2018Device	CLASS II	GE Vivid E95 ultrasound system Product The device recalled	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL	Device Malfunction	Nationwide

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2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide