FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
- Recall number
- Z-0383-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens, ONCOR Avante Garde, Part No.: 58 63 472,Medical Charge particle radiation therapy system, with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
- Status
- Terminated
- Initiated
- 2007-03-23
- Posted
- 2007-12-01
- Terminated
- 2011-02-11
- Reason
- Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
- Root cause
- Device Design
- Action
- The firm has issued a Customer Safety Advisory Notice dated 12/6/2006, to all sites that have the pre-R2.0 OPTIVUE Flat Panel Positioners installed. Users will have a new microswitch-based collision detection system, installed free of charge.
- Quantity
- 47 units
- Distribution
- Worldwide Distribution- USA including MA, ME, NJ, NY, PA, MD, WV, NC, SC, GA, FL, AL, TN, KY, OH, IN, MI, IA, WI, SD, ND, MT, IL, NE, LA, OK, TX, WY, NV, CA, AK AND AR, and countries of Serbia, Australia, Austria, Belgium, Canada, Denmark, El Salvador, France, Germany, Hungary, India, Ireland, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, China, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, Ukraine, UK.
- Lot, serial or model codes
- Model Number 5863472, Serial Numbers 3737 3738 3739 3758 3806 3817 3852 3856 3884 3891 3895 3896 3904 3905 3912 3926 3929 3934 3937 3938 3944 3987 3988 4016 4049 4079 4082 4095 70-4077 70-4113 70-4163 70-4168 70-4169 70-4184 70-4188 70-4197 70-4201 70-4213 70-4217 70-4223 70-4283 70-4291 70-4297 70-4311 70-4314 70-4324 70-4325
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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