Pulsox-3Si. LCD, SpO2, PR, Pulse strength bar, Motion artifact, Low battery message, Error message, Event mark, Measurin
FDA device recall Z-0289-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Minolta Corp
- 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.
- Action taken
- Distributor provided customer list to Konica Minolta who initiated phone calls to the customers on 11/14/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 291
- Distribution
- The units were shipped to one distributor in Utah.
- Date initiated
- 2003-11-14
- Date posted
- 2004-07-20
- Date terminated
- 2004-04-14
- Location
- Ramsey, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI (K010413) | Konica Minolta Sensing, Inc. | 2001-08-02 |