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Class 2 Device Recall CyberMED Version 2.1 Pharmacy SoftwareAspyra |
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Date Initiated by Firm |
January 31, 2007 |
Date Posted |
March 31, 2007 |
Recall Status1 |
Terminated 3 on July 22, 2011 |
Recall Number |
Z-0686-2007 |
Recall Event ID |
37277 |
Product Classification |
Medication Administration - Product Code NXS
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Product |
Aspyra, Inc. CyberMED Version 2.1 Pharmacy Software |
Code Information |
Version 2.1 |
Recalling Firm/ Manufacturer |
Aspyra, Inc. 26115 Mureau Rd Calabasas CA 91302-3177
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For Additional Information Contact |
Martin D. Sargent 800-437-9000 Ext. 2107
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Manufacturer Reason for Recall |
Medications prescribed for one patient were printed on the Medication Administration Record (MAR) of another patient.
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FDA Determined Cause 2 |
Other |
Action |
Current customers were mailed a Recall Letter January 31,2007 explaining the issue and informing the customers of an upcoming CyberMED Version 2.1 maintenance software release to correct the potential issue. A fax-back Acknowledgement of Receipt form was sent with the Recall Letter. |
Quantity in Commerce |
10 |
Distribution |
Nationwide to: CA, GA, IN, MI, MN, MS, NC, ND, & OK |
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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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