Z-2715-2024Class II

GM60A. Digital Diagnostic Mobile X-Ray System

Name: Z-2715-2024 GM60A. Digital Diagnostic Mobile X-Ray System
Creator: NeuroLogica Corporation
Published: 2024-07-08
License: https://open.fda.gov/license/

Samsung HME America, Inc. / initiated 2024-07-08 / Open, Classified / root cause: design

FDA source

NeuroLogica Corporation began a recall of GM60A. Digital Diagnostic Mobile X-Ray System on 2024-07-08. FDA classified it as Class II and gives the reason as "Potential for the anti-fall system of the device arm to fail". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2715-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-08
Posted: 2024-08-22
Recalling firm: Samsung HME America, Inc.
Product: GM60A. Digital Diagnostic Mobile X-Ray System.
Product code: IZL System, X-Ray, Mobile
Reason for recall: Potential for the anti-fall system of the device arm to fail.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were emailed an "Urgent -- Medical Device Correction; GM60A Digital X-ray Imaging System" notification the week of 7/8/2024. The notification instructs consignees to share the recall notification with those in their organization that utilize the affected devices and forward the notification if devices have been transferred. Affected systems may continue to be used. Consignees are to check on-hand devices to confirm if they are affected by the field action and return the response form back indicating any devices that require correction by email to [email protected] within 10 business days. Samsung Electronics will send service engineers to affected consignees to correct devices free of charge. Service will be coordinated by Samsung Electronics and should be completed by October 2024. Consignees with any questions are to contact their local Samsung Electronics representative.
Quantity in commerce: 31 units
Distribution: US Nationwide distribution in the states of AR, CT, GA, IN, KS, MA, MD, MO, MS, NC, ND, NJ, NV, OH, PA, VA, WV & DC.
Product codes and lots: UDI: 08806088511153/ 08806088088266; Serial No. G69812, G69821, G69824, G69986, G69987, G71422, G71425, G71431, G71434, G71795, G71798, G71802, G72052, G72053, G72264, G72279, G72296, G72301, G72310, G72313, G72319, G72320, G72481, G72484, G72595, G72601, G72853, G72875, G73179, G73184, G73542; Samsung Serial No. 50WFM9BG900003M, 50WFM9BG900004J, 50WFM9BG900005H, 50WFM9BGA00001T, 50WFM9BGA00002B, 50WFM9BH300001E, 50WFM9BH300002W, 50WFM9BH300003Z, 50WFM9BH300004N, 50WFM9BH400001X, 50WFM9BH400002W, 50WFM9BH400003A, 50WFM9BH500001H, 50WFM9BH500002Y, 50WFM9BH600001P, 50WFM9BH600002L, 50WFM9BH600003F, 50WFM9BH600004Y, 50WFM9BH600005W, 50WFM9BH600006N, 50WFM9BH600007K, 50WFM9BH600008J, 50WFM9BH700002B, 50WFM9BH700001P, 50WFM9BH700003M, 50WFM9BH700004E, 50WFM9BH800002E, 50WFM9BH800003D, 50WFM9BH900001X, 50WFM9BH900002D, 50WFM9BHB00001T.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2715-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2715-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-28	2024-08-22

Product code IZL

K150097Class IIGm60a-32S & Gm60a-40SSamsung Electronics Co., Ltd. / cleared 2015-02-19

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)