Siemens Medical Solutions USA, Inc POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Numbers for model 1148902: 01000 through 01267, 02001 through 02117. Serial numbers for model4784505: 03001 through 035158, 04001 through 04136, and 05001 through 05098
Products Sold
Serial Numbers for model 1148902: 01000 through 01267, 02001 through 02117. Serial numbers for model4784505: 03001 through 035158, 04001 through 04136, and 05001 through 05098
Siemens Medical Solutions USA, Inc is recalling POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505. due to Orbital gears may exhibit excess wear. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Orbital gears may exhibit excess wear
Recommended Action
Per FDA guidance
The recalling firm issued Update Instructions, AX077/04/S, to Siemen''s Customer Service Representative (CSR) to visit affected sites and check the orbital gears for excessive wear. If the CSR finds gears exhibiting excessive wear the orbital gears will be replaced. If no wear is observed the gears will be lubricated as a preventive measure.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026