Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copy
FDA device recall Z-2137-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Civco Medical Instruments Inc
- Reason for recall
- A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
- Action taken
- On 06/16/08 Civco Medical Solutions issued an Urgent-Medical Device Correction letter to all its customers by certified mail. This letter states the circumstances in which the device works incorrectly, a temporary work around and the information that the new software version 6.7 will address the issue. The software will be released in August of 2008. Attached to the letter is an ISOLOC Device Correction Notification Customer Feedback form which is to be completed and returned acknowledging the receipt of the Device Correction Notification.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 235: 163 version 6.6, 60 version 6.5 and 12 version 6.0
- Distribution
- Worldwide Distribution --- USA including Puerto Rico and countries of Korea, Portugal, and United Kingdom.
- Date initiated
- 2008-06-18
- Date posted
- 2008-09-18
- Date terminated
- 2011-03-31
- Location
- Kalona, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEREOTACTIC IRRADIATION SYSTEM (K904908) | Northwest Medical Physics Center | 1991-06-06 |