Smiths Medical Medfusion Syringe Infusion Pumps Recalled for Alarm System Failures
Smiths Medical is recalling certain Medfusion syringe infusion pumps due to intermittent alarm system failures that may occur during power-on self-tests outside the warranty period.
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: FDA Class II recall with no reported illnesses or injuries. The malfunction affects critical alarm and diagnostic systems on infusion pumps, representing a risk of harm, but no patient injuries have been documented.
Plain-English summary
Smiths Medical ASD Inc. is recalling certain Medfusion 3500, 4000, 3010, and 3010A syringe infusion pumps that received replacement main boards between April 2012 and June 2015. The recall affects approximately 31,065 pumps serviced with replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562, and G6002728.
The affected pumps may experience intermittent errors with the Supercap power-on self-test (POST) and backup audible alarm systems. These alarm errors occur at startup when the pump performs its self-test routine and may appear outside the pump's warranty period.
The affected pumps were distributed nationwide throughout the United States, including Puerto Rico, the U.S. Virgin Islands, Guam, and the Northern Mariana Islands, as well as to government, military, and foreign customers. This recall was initiated in 2015.
The recalled product
- Product
- Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and…
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Infusion Pump
Distribution
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