SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM monitors at 1 time Part
FDA device recall Z-0373-2010 · 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
- 18,594 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) (K070588) | Philips Medical Systems | 2007-03-20 |