Pulsox-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.
FDA Recall Z-0290-04 · Posted 2004-07-20
Advertisement
Recalling FirmMinolta Corp
Recall StatusTerminated
Product CodeDQA
Date Initiated2003-11-14
Date Terminated2004-04-14
Product Quantity9
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.
Advertisement