SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"dis
FDA device recall Z-0372-2010 · posted 2009-11-23 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker
- Action taken
- Customer notifications dated October 2009, in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. Customers will be instructed to lower the volume setting while using existing units during the first notification. As part of the second notification to the customers, the field action correction will be a customer installable software upgrade. Customers may contact Philips Response Center with questions or concerns at 1.800.722.9377. On December 14, the firm issued the follow-up notification letter implementing the action plan to provide the software upgrade kit for installation and instructions.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 30, 833 units
- Distribution
- Nationwide Foreign: Canada Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Ch
- Date initiated
- 2009-10-30
- Date posted
- 2009-11-23
- Date terminated
- 2013-02-20
- 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 |
|---|---|---|
| SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS (K090483) | Philips Medical Systems | 2009-03-20 |