GM60A. Digital Diagnostic Mobile X-Ray System.
FDA device recall Z-2715-2024 · posted 2024-08-22 · Open, Classified
Recall details
- Recalling firm
- NeuroLogica Corporation
- Reason for recall
- Potential for the anti-fall system of the device arm to fail.
- Action taken
- 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 fcsa@neurologica.com 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 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.
- Date initiated
- 2024-07-08
- Date posted
- 2024-08-22
- Location
- Danvers, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GM60A-32S & GM60A-40S (K150097) | Samsung Electronics Co., Ltd. | 2015-02-19 |