Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Reported: June 5, 2019 Initiated: May 6, 2019 #Z-1691-2019
Product Description
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
Reason for Recall
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
Details
- Recalling Firm
- NeuroLogica Corporation
- Units Affected
- 288 systems
- Distribution
- US Nationwide Distribution
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
Samsung GM85 Mobile Digital X-ray Imaging System Product Usage: The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. Recalled by NeuroLogica Corporation. Units affected: 288 systems.
Why was this product recalled? ▼
Potential issue related to the operation of the safety latch within the column that supports the arm due to a possibility of potential bodily harm due to a fall of the arm in an unlikely event that the column wire breaks.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2019. Severity: Moderate. Recall number: Z-1691-2019.
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