# FDA WARNING_LETTER - Union Square Medical Imaging & Mammography - February 11, 2014

Source: https://www.keypedia.com/records/warning_letter/union-square-medical-imaging-mammography/2393e1c8-2a7e-4369-9abb-09d7eba51dcb

> FDA WARNING_LETTER for Union Square Medical Imaging & Mammography on February 11, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Union Square Medical Imaging & Mammography
- Inspection Date: 2014-02-11
- Product Type: Devices
- Office Name: New York District Office
- Summary: On January 29 and February 11, 2014, an FDA inspection of Union Square Medical Imaging & Mammography, P.C. revealed serious violations of the Mammography Quality Standards Act (MQSA).

Key violations include:
- **Level 1:** Missing phantom QC records for unit 3 for over 4 weeks during a 12-week period (21 CFR 900.12(e)(2) and (d)(2)).
- **Level 2:** Failure to follow FFDM manufacturer QC procedures (excluding monitor & printer QC) for digital unit 3 (21 CFR 900.12(e)(6)).
- **Level 2:** Failure to follow manufacturer recommended QC procedures for the monitor of digital unit 3 (21 CFR 900.12(e)(6)).
- **Level 2:** Failure to produce documentation verifying an interpreting physician met continuing education requirements (21 CFR 900.12(a)(1)(ii)(B)).
- **Level 2:** Failure to produce documentation verifying multiple radiologic technologists met continuing experience requirements (200 mammography exams in 24 months) and/or 8 hours of training in each mammographic modality (21 CFR 900.12(a)(2)(iv)(A), 21 CFR 900.12(

## Related Officers

- [Leonard Lucey](https://www.keypedia.com/people/leonard-lucey/61d231d2-abb0-4e3b-ad45-f59a5c2d8ba4)
- [Daniel Hamburger](https://www.keypedia.com/people/daniel-hamburger/a2f5d7e8-8ca1-4233-b434-2b0257d9989b)
- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)
- [Mark Horberg](https://www.keypedia.com/people/mark-horberg/c317530f-ad07-46e6-bf31-a586d7bf937e)
- [James R. Wormuth](https://www.keypedia.com/people/james-r-wormuth/c7490156-c621-4e15-ae4c-d568fb5435ad)

Company: https://www.keypedia.com/companies/union-square-medical-imaging-mammography/ebf98719-61b7-4c19-bd22-3596e1cc74f5

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d