Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is
FDA device recall Z-0973-2014 · posted 2014-02-28 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)
- Action taken
- Medtronic Navigation Inc. issued Notiifcation on 3/4/14 and included thee errata sheet to all affected customers updating the missing and incorrect information and ensure that labeling is now in compliance with 21 CFR Part 1020.30(h). This will be followed by a software update that contains the same information on the errata sheet, which serves to correct the electronic version of the Instructions for Use. The paper errata sheet will be sent via traceable means and the software upgrade will be performed by Medtronic Service either through remote access or by site visit of Medtronic service personnel. For further questions please call (978) 698-6000.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- OXO
- Quantity affected
- 449 in US
- Distribution
- USA (nationwide) Distribution
- Date initiated
- 2013-07-25
- Date posted
- 2014-02-28
- Date terminated
- 2019-04-17
- Location
- Littleton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| O-ARM IMAGING SYSTEM (K092564) | Medtronic Navigation, Inc. (Littleton) | 2010-06-17 |