FDA Medical Device Recalls (openFDA)
Med Tec Inc dba CIVCO Medical Solutions: Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
- Recall number
- Z-1613-2008
- Recalling firm
- Med Tec Inc dba CIVCO Medical Solutions
- Product
- Fiducial Markers (2mm spheres) Bone gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-805, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
- Status
- Terminated
- Initiated
- 2008-02-28
- Posted
- 2008-05-21
- Terminated
- 2008-07-02
- Reason
- Mislabeled: Fiducial markers were incorrectly labeled. They are marked (2mm spheres) Bone gold markers, but contain (0.9x3mm cylindrical) Soft tissue gold markers.
- Root cause
- Labeling mix-ups
- Action
- Consignees were notified via telephone beginning 2/28/08 and a Recall Notification letter sent on 2/29/08. Users were requested to return any affected products for a replacement. They were also requested to return a recall notification form indicating the amount of affected product in their inventory. For additional information, call 800-842-8688.
- Quantity
- 36/3-marker pouches
- Distribution
- Nationwide Distribution including states of WA, PA, DE, AL, CT, WI, FL, TX, MN, and IL.
- Lot, serial or model codes
- Lot Number: 080117-01
- 510(k) numbers
- ["K071614"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1000143606
- Firm city
- Orange City
- Firm state
- IA
- 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