Z-1124-2014 Class II Terminated
FDA device recall Z-1124-2014 was initiated by Medical Information Technology, Inc. on January 17, 2014 and is designated Class II. Reason for recall: Potential for patient results being removed from LAB/EMR. The recall status is terminated (terminated June 6, 2016). Affected quantity: 737.
Recall Details
- Product Type
- Devices
- Report Date
- March 12, 2014
- Initiation Date
- January 17, 2014
- Termination Date
- June 6, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 737
Product Description
MEDITECH Microbiology - Calculator/data processing module, for clinical use.
Reason for Recall
Potential for patient results being removed from LAB/EMR.
Distribution Pattern
Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.
Code Information
Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13.