Z-2303-2012Class II

Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278...

Name: Z-2303-2012 Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278...
Creator: Philips Healthcare Inc.
Published: 2012-08-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-08-15 / Terminated / root cause: manufacturing process

FDA source

Philips Healthcare Inc. began a recall of Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for... on 2012-08-15. FDA classified it as Class II and gives the reason as "Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2303-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-15
Posted: 2012-08-30
Terminated: 2014-03-13
Recalling firm: Philips North America LLC
Product: Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. The SureSigns VSi vital signs monitor is for measurement of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility
Product code: DXN System, Measurement, Blood-Pressure, Non-Invasive
Reason for recall: Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 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, MALAYSIA,NAMIBIA NETHERLANDS, NORWAY, POLAND, PORTUGAL, RWANDA SAUDI ARABIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
Product codes and lots: Serial Number Range CN14800101-CN14801360 CN21201362-CN21202440, CN21202525, SP13701043, USPP101007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2303-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2303-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-30

Product code DXN

K112652Class IISuresigns Vs2+ -Suresigns VsiPhilips Medical Systems / cleared 2011-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)