Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
FDA device recall Z-1056-2024 · posted 2024-02-09 · Open, Classified
Recall details
- Recalling firm
- NeuroLogica Corporation
- Reason for recall
- Mobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm.
- Action taken
- An "Urgent - Medical Device Correction" notice was issued via email on December 28, 2023, cosigned by representatives of Samsung Electronics Co., Ltd. and NeuroLogica Corp. The notice describes the product, problem and actions to taken. The customers were instructed to continue to use the GM85 systems and Service Engineers will contact you to arrange for on-site correction. Share this notice with users within your organization or anywhere the devices may have been transferred. Customer Reply Form are to be completed and returned via email to fsca@neurologica.com. Contact your local representative with questions email: SupportBI@bostonimaging.com, 1-800-976-0980.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 261 devices
- Distribution
- US Nationwide Distribution including states of: AL, AR, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, PA, SD, TN, TX, VA, WI & WV.
- Date initiated
- 2023-12-28
- Date posted
- 2024-02-09
- Location
- Danvers, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GM85 (K222353) | Samsung Electronics Co., Ltd. | 2022-09-29 |