Medical Information Technology Recalls MEDITECH Microbiology Calculator Module
Medical Information Technology, Inc. is recalling MEDITECH Microbiology calculator modules due to a risk of patient results being removed from laboratory and electronic medical record systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves the potential removal of patient results from clinical systems, which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medical Information Technology, Inc. is recalling the MEDITECH Microbiology Calculator/data processing module, which is used for clinical purposes. The recall involves 737 units of the software module.
The recall was initiated because there is a potential for patient results to be removed from the Laboratory (LAB) and Electronic Medical Record (EMR) systems. This data integrity issue could affect the availability of clinical information.
The affected products were distributed nationwide in the United States and to Canada, Ireland, and the United Kingdom. The specific model and release numbers involved are MAGIC Releases 5.6, 5.66 and Server Releases 5.6, 5.65, 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13. Users of this software should contact the manufacturer for further instructions on how to address the potential data loss.
The recalled product
- Product
- MEDITECH Microbiology - Calculator/data processing module, for clinical use.
- Manufacturer
- Medical Information Technology, Inc.
- Category
- Medical Device — Software
- Affected units
- 737
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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.
Distribution
Distributed nationwide across the United States.
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