MAMMOMAT Revelation recall
MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual…
Why was MAMMOMAT Revelation 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers (distributed in the US): 1026 1057 1348 1426 1027 1274 1292 1360 1324 1728 1372 1744 1036 1038 1620 1235 1751 1423 1379 1425 1342 1740 1445 1650 1058 1409 1277 1025 1253 1225 1749 1747 1422 1275 1228 1449 1707 1767 1387 1391 1206 1217 1250 1082 1357 1354 1256 1031 1339 1034 1219 1437 1289 1359 1045 1429 1408 1717 1051 ***Updated 8/18/2020*** 1775 1784 1785 1795 1797
- Product
- MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 230 worldwide (64 US)
- Distribution
- US Nationwide distribution.
- Recall date
- June 24, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)