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.
FDA Recall Z-0289-04 · Posted 2004-07-20
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Recalling FirmMinolta Corp
Recall StatusTerminated
Product CodeDQA
Date Initiated2003-11-14
Date Terminated2004-04-14
Product Quantity291
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.
Firm Action
Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.
Root Cause
Other
Distribution Pattern
The units were shipped to one distributor in Utah.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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