• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Medfusion 4000 V1.0 &V1.1 Syringe Infusion Pump

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 1 Device Recall Medfusion 4000 V1.0 &V1.1 Syringe Infusion Pump see related information
Date Initiated by Firm February 14, 2012
Date Posting Updated August 01, 2012
Recall Status1 Terminated 3 on November 14, 2012
Recall Number Z-2107-2012
Recall Event ID 61247
510(K)Number K111386  
Product Classification Pump, infusion - Product Code FRN
Product Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78.

Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
Code Information 2000245, 2000246, 2000247, 2000248, 2000249, 2000250, 2000251, 2000252, 2000253, 2000254, 2000255, 2000256, 2000257, 2000258, 2000259, 2000260, 2000261, 2000262, 2000263, 2000264, 2000265, 2000266, 2000267, 2000268, 2000269, 2000270, 2000271, 2000272, 2000273, 2000274, 2000275, 2000276, 2000277, 2000278, 2000279, 2000280, 2000281, 2000282, 2000283, 2000284, 2000285, 2000286, 2000287, 2000288, 2000289, 2000290, 2000291, 2000292, 2000293, 2000294, 2000295, 2000296, 2000297, 2000298, 2000299, 2000300, 2000301, 2000302, 2000303, 2000304, 2000305, 2000307, 2000308, 2000309, 2000310, 2000311, 2000312, 2000313, 2000314, 2000315, 2000316, 2000317, 2000318, 2000319, 2000320, 2000321, 2000322, 2000323, 2000324, 2000325, 2000326, 2000327, 2000328, 2000329, 2000330, 2000331, 2000332, 2000333, 2000334, 2000336, 2000337, 2000338, 2000339, 2000340, 2000341, 2000342, 2000343, 2000344, 2000345, 2000346, 2000347, 2000348, 2000349, 2000350, 2000351, 2000352, 2000353, 2000354, 2000355, 2000356, 2000357, 2000358, 2000359, 2000360, 2000361, 2000362, 2000363, 2000364, 2000365, 2000366, 2000367, 2000368, 2000369, 2000370, 2000371, 2000372, 2000373, 2000374, 2000375, 2000376, 2000377, 2000378, 2000379, 2000380, 2000381, 2000382, 2000383, 2000384, 2000385, 2000386, 2000387, 2000388, 2000389, 2000390, 2000391, 2000392, 2000393, 2000394, 2000395, 2000396, 2000397, 2000398, 2000399, 2000400, 2000401, 2000402, 2000403, 2000404, 2000405, 2000406, 2000408, 2000409, 2000412, 2000413, 2000414, 2000415, 2000416, 2000417, 2000418, 2000419, 2000422, 2000423, 2000425, 2000426, 2000428, 2000430, 2000431, 2000433, 2000434, 2000436, 2000437, 2000438, 2000439, 2000440, 2000441, 2000442, 2000443, 2000445, 2000446, 2000447, 2000448, 2000449, 2000450, 2000451, 2000452, 2000453, 2000454, 2000455, 2000456, 2000457, 2000458, 2000459, 2000460, 2000461, 2000462, 2000463, 2000464, 2000465, 2000466, 2000467, 2000468, 2000469, 2000470, 2000471, 2000472, 2000473, 2000474, 2000475, 2000476, 2000477, 2000478, 2000479, 2000480, 2000481, 2000482, 2000483, 2000484, 2000485, 2000486, 2000487, 2000488, 2000489, 2000490, 2000491, 2000492, 2000493, 2000494, 2000495, 2000496, 2000497, 2000498, 2000499, 2000500, 2000501, 2000502, 2000503, 2000504, 2000505, 2000506, 2000507, 2000508, 2000509, 2000510, 2000511, 2000512, 2000513, 2000514, 2000515, 2000516, 2000517, 2000518, 2000519, 2000520, 2000521, 2000522, 2000523, 2000524, 2000525, 2000526, 2000527, 2000528, 2000529, 2000530, 2000531, 2000532, 2000533, 2000534, 2000535, 2000536, 2000537, 2000538, 2000539, 2000540, 2000541, 2000542, 2000543, 2000544, 2000545, 2000546, 2000547, 2000548, 2000549, 2000550, 2000551, 2000552, 2000553, 2000554, 2000555, 2000556, 2000557, 2000558, 2000559, 2000560, 2000561, 2000562, 2000563, 2000564, 2000565, 2000566, 2000567, 2000568, 2000569, 2000570, 2000571, 2000572, 2000573, 2000574, 2000575, 2000576, 2000577, 2000578, 2000579, 2000580, 2000581, 2000582, 2000583, 2000584, 2002080, 2002081, 2002082, 2002083, 2002084, 2002085, 2002086, 2002087, 2002089, 2002090, 2002091, 2002092, 2002093, 2002094, 2002095, 2002096, 2002097, 2002098, 2002099, 2002100, 2002101, 2002102, 2002103, 2002104, 2002105, 2002106, 2002107, 2002108, 2002109, 2002110, 2002111, 2002112, 2002113, 2002114, 2002115, 2002116, 2002117, 2002118, 2002119, 2002120, 2002121, 2002122, 2002123, 2002124, 2002125, 2002128, 2002129, 2002130, 2002131, 2002132, 2002133, 2002134, 2002135, 2002136, 2002137, 2002138, 2002139, 2002140, 2002141, 2002142, 2002143, 2002144, 2002145, 2002146, 2002147, 2002148, 2002149, 2002150, 2002151, 2002152, 2002153, 2002154, 2002155, 2002156, 2002157, 2002158, 2002159, 2002160, 2002161, 2002162, 2002163, 2002164, 2002165, 2002166, 2002167, 2002168, 2002169, 2002170, 2002171, 2002173, 2002174, 2002175, 2002176, 2002177, 2002178, 2002179, 2002180, 2002181, 2002182, 2002183, 2002184, 2002185, 2002186, 2002187, 2002188, 2002189, 2002190, 2002204, 2002205, 2002206, 2002207, 2002208, 2002209, 2002210, 2002211, 2002212, 2002213, 2002
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
651-633-2556
Manufacturer Reason
for Recall
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
FDA Determined
Cause 2
Software design
Action Consignees of Medfusion¿ 4000 pumps with software version 1.0 & 1.1 were visited by a Smiths Medical representative on 2/14/12 informing them that their pumps require a software upgrade. A record of this software upgrade was documented as part of the records for this action.
Quantity in Commerce 607 pumps (257 USA, 350 Canada)
Distribution Worldwide Distribution -- USA, including the state of CA, and country of Canada.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = SMITHS MEDICAL MD, INC.
-
-