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U.S. Department of Health and Human Services

Class 2 Device Recall Pulsox

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 Class 2 Device Recall Pulsoxsee related information
Date Initiated by FirmNovember 14, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 14, 2004
Recall NumberZ-0290-04
Recall Event ID 27692
510(K)NumberK010413 
Product Classification Oximeter - Product Code DQA
ProductPulsox-3iA. LCD, Sp02, PR, Pulse strength bar, motion artifact, low battery message, error message, low Sp02 message, event mark. Measuring range Sp02 0 to 100, pulse rate 20 to 250, measuring accuracy Sp02 +/-2% (70 to 100), pulse rate +/- 2, Sp02 alarm, audible and visible, probe type finger, multi-site, paitent range adult to neonatal, memory function approx. 24 hrs, printer/recorder optional accessory, output RS232 w/optional interface module, power supply 2 AAA batteries, Battery life approx. 48 hrs, size 42x68x20mm, weight 42g.
Code Information Model 3iA, Serial Nos.: 23001201; 23001204; 23001206; 23001210; 23001212-23001214; 23001216; 23001217.
Recalling Firm/
Manufacturer		 Minolta Corp
101 Williams Dr
Ramsey NJ 07446-1217
For Additional Information ContactMr. Takaaki Saito
201-529-6063
Manufacturer Reason
for Recall		Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts.
FDA Determined
Cause 2		Other
ActionDistributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.
Quantity in Commerce9
DistributionThe units were shipped to one distributor in Utah.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQA
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