MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
Reported: June 24, 2020 Initiated: May 7, 2020 #Z-2388-2020
Product Description
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.
Reason for Recall
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 230 worldwide (64 US)
- Distribution
- US Nationwide distribution.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 230 worldwide (64 US).
Why was this product recalled? ▼
If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy system is being used, the tube arm's manual movement range is decreased from +/-15 deg. to +/- 6 deg. This limitation may lead to difficulties in removing the vacuum biopsy system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2020. Severity: Moderate. Recall number: Z-2388-2020.
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