DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, pa
FDA device recall Z-2781-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Software allows incorrect patient or patient history to be displayed.
- Action taken
- Medtronic Navigation sent a "FIELD SAFETY NOTICE" letter dated June 2, 2011 to all affected customers. The letter identified the product, problem and description of the corrective action. The letter states that Medtronic field representatives will visit each consumer/user and upgrade the version of DICOM Q/R to 1.1.5. Further information is available by contacting Medtronic Navigation Technical Services at 1-800-595-9709.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 90
- Distribution
- Worldwide distribution - USA (nationwide) -- including states of: TX, NC, ID, FL, OH, UT, CA, TN, IL, AZ, NE, LA, PA, OR, AR, MI, NJ, MD and countries of: Canada, Denmark, Finland, Great Britain, Hung
- Date initiated
- 2011-06-02
- Date posted
- 2011-07-11
- Date terminated
- 2011-07-12
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEALTHSTATION SYSTEM UPDATE (K050438) | Medtronic Surgical Navigation Technologies | 2005-06-02 |