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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 Pulsox see related information
Date Initiated by Firm November 14, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 14, 2004
Recall Number Z-0289-04
Recall Event ID 27692
510(K)Number K010413  
Product Classification Oximeter - Product Code DQA
Product Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measuring range Sp02 (%) 0 to 100, Pulse rate 20 to 250, Measuring accuracy +/- 2% (70 to 100), Pulse rate +/- 2%, Sp02 alarm, no, Probe type, finger, multi-site, Patient 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 hours, size: 42x68x20mm, weight 42g.
Code Information Model 3Si, Serial Nos: 22001453-22001469; 22001471-22001512; 22001514-22001599; 22001600-22001626; 22001628-22001632; 22001635-22001643; 22001645-22001651; 22001653-22001659; 22001661-22001676; 22001678-22001683; 22001685-22001686; 22001688-22001691; 22001712-22001714; 22001717-22001719; 22001721-22001723; 22001725; 22001727-22001732; 22001734-22001737; 22001740-22001745; 22001747-22001765; 22001767-22001770; 22001772; 22001776; 22001860; 22001862; 22001865; 22001868; 22001879; 22001881; 22001882; 22001885; 22001887; 22001893; 22001897; 22001899; 22001905.  
Recalling Firm/
Manufacturer		 Minolta Corp
101 Williams Dr
Ramsey NJ 07446-1217
For Additional Information Contact Mr. 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
Action Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.
Quantity in Commerce 291
Distribution The units were shipped to one distributor in Utah.
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 = DQA and Original Applicant = KONICA MINOLTA SENSING, INC.
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