FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device.
- Recall number
- Z-1254-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- AXIOM Sireskop SD Model numbers 8890415 and 8890407. The product is intended for use as radiographic and fluoroscopic imaging device.
- Status
- Terminated
- Initiated
- 2009-01-08
- Posted
- 2009-05-06
- Terminated
- 2009-09-01
- Reason
- During interventional use and applications, the possibility exists for liquids to enter the systems.
- Root cause
- Equipment maintenance
- Action
- A Customer Safety Advisory Notice dated January 8, 2009 was issued to affected customers via Update Instructions AX069/08/S. This letter informed customers of the potential issues and provided instructions to avoid its occurrence. The firm has released an Addendum to the User Manual warning of the potential hazards if liquids penetrate the systems during interventional use and applications. Direct questions about this recall to Siemens Medical Solutions USA, Inc. by calling 1-610-219-6300.
- Quantity
- 240 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Serial numbers: 51010, 71136, 51007, 51008, 71019, 71080, 71172, 71067, 41012, 71015, 71038, 71102, 71104, 71169, 51006, 51011, 51024, 51028, 71026, 71039, 71083, 71117, 71119, 41027, 71120, 71121, 41028, 71137, 71138, 71149, 71158, 71161, 71167, 71168, 71170, 51060, 71160, 51026, 71030, 71059, 71033, 71037, 41006, 51052, 51064, 71001, 71082, 71114, 71141, 71148, 71152, 71156, 51046, 71181, 51013, 51044, 71075, 71098, 51054, 71020, 71021, 71074, 71088, 41026, 71135, 71140, 71055, 71006, 71017, 71042, 71073, 71162, 71174, 41003, 51049, 71053, 71128, 71131, 41022, 71096, 71099, 71129, 51009, 51036, 51045, 71069, 71087, 71144, 41008, 71014, 71016, 71028, 71109, 71130, 71004, 71051, 71090, 71157, 51029, 51030, 51069, 71009, 71011, 71034, 71035, 71126, 71127, 71145, 51003, 51016, 71022, 71029, 71164, 51043, 51070, 71061, 71064, 71110, 71116, 51001, 51057, 41014, 71124, 71133, 51012, 51050, 71070, 71142, 71095, 41011, 51047, 71023, 71076, 71081, 71084, 51041, 41010, 71032, 41029, 71002, 71065, 71105, 71115, 51005, 71068, 51017, 51018, 51023, 71043, 71046, 41020, 71091, 71092, 71101, 71108, 71139, 71146, 71150, 71155, 71178, 51015, 51059, 51066, 71013, 71057, 71062, 71097, 41013, 71024, 41023, 71086, 51037, 71010, 71106, 71112, 51065, 51068, 71008, 41017, 71078, 41024, 71079, 71111, 71018, 71147, 51002, 71040, 41002, 51019, 51020, 41005, 51033, 41007, 51040, 51048, 51051, 51055, 51061, 71003, 71007, 71012, 41018, 71025, 41019, 71045, 71063, 71100, 71103, 71113, 71122, 71125, 71153, 71154, 71159, 71163, 71171, 71173, 71177, 51004, 51021, 51025, 51058, 71048. 71058, 71060, 71072, 41001, 51022, 51031, 51035, 51039, 71027, 71175, 51063, 71005, 71066, 71089, 71165, 71166, 71123, 71151, and 51056.
- 510(k) numbers
- ["K051602"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28