Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The Sur
FDA device recall Z-2303-2012 · posted 2012-08-30 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount
- Action taken
- Philips sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers using the VSi/VS2+ with the GCX wall mount are instructed to complete and fax a Customer Reply Wall Mount Order Card to the Business Unit or Key Market indicating the number of wall mounts in use. Upon receipt of the Customer Reply Wall Mount Order Card, Philips will send a replacement of the mounting hardware. Customers should contact their local Philips representative for questions regarding this recall.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DXN
- Quantity affected
- 2314 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, DENMARK, EL SALVADOR, FRANCE, GERMANY, ICELAND, INDIA, IRELAND ISRAEL, ITALY, JORDAN, KENYA, LEBANON,
- Date initiated
- 2012-08-15
- Date posted
- 2012-08-30
- Date terminated
- 2014-03-13
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURESIGNS VS2+ -SURESIGNS VSI (K112652) | Philips Medical Systems | 2011-10-11 |