M1020B PulseOximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M
FDA device recall Z-0184-2007 · posted 2006-11-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- Unexpected pulse oximetry (Sp02) readings (100%) over time when sensor is not attached to patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM
- Action taken
- Philips issued a Customer Letter and Urgent Device Correction letter to consignees on 09/21/06. Users were notified of the problem and provided with Instructions to Mitigate Risk. A software upgrade to: version D.00.61 and Sp02 FW A.01.46 is mandatory.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQA
- Quantity affected
- 442 units
- Distribution
- Worldwide, including USA, Canada, Australia, China, Hong Kong, India, Indonesia, Japan, Phillipines, Singapore, Taiwan, Thailand, Vietnam, Argentina, Brazil, Chile, Colombia, El Salvador, Jamaica, Mex
- Date initiated
- 2006-09-21
- Date posted
- 2006-11-16
- Date terminated
- 2020-08-11
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER (K033715) | Philips Medical Systems, Inc. | 2004-02-13 |