| | Class 2 Device Recall |  |
| Date Initiated by Firm | May 13, 2003 |
|---|
| Date Posted | June 17, 2003 |
|---|
| Recall Status1 |
Terminated 3 on April 23, 2004 |
| Recall Number | Z-0926-03 |
|---|
| Recall Event ID |
26364 |
| Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
| Product | Misys Laboratory System, version 5.3 |
|---|
| Code Information |
Version 5.3 |
| FEI Number |
1000306472
|
Recalling Firm/
Manufacturer |
Misys Healthcare Systems
4801 E Broadway Blvd
Tucson AZ 85711
|
| For Additional Information Contact | Barbara Brown
520-570-2000 |
|---|
Manufacturer Reason
for Recall | Two clients reported Quality Assurance dates could not be entered after 5/19/03. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Product Safety Notice number PSN-03-L24 was issued on May 13, 2003 to all affected customers. It contained an effective workaround and communicated that the software fix was available and also included that for those clients that wanted to install it. Clients are reminded to return acknowledgement cards included in the mailing. |
|---|
| Quantity in Commerce | 466 |
|---|
| Distribution | Nationwide, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Kingdom, United Arab Emirates, |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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