Z-1942-2012Class II

Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera...

Name: Z-1942-2012 Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera...
Creator: Philips Healthcare Inc.
Published: 2012-06-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-06-14 / Terminated / root cause: software

FDA source

Philips Healthcare Inc. began a recall of Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping... on 2012-06-14. FDA classified it as Class II and gives the reason as "Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1942-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-14
Posted: 2012-07-05
Terminated: 2017-03-14
Recalling firm: Philips North America LLC
Product: Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the connection by serving as a central point for data exchange. The data consists only of demographic patient information, schedules, textual information and text reports.
Product code: OUG Medical Device Data System
Reason for recall: Xcelera Connect R2.1 L 1 SP2 , incomplete information arriving from unformatted reports interface
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an "URGENT-FIELD SAFETY NOTICE" letter dated June 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Philips representative will contact customers when the upgrade becomes available. Contact your local Philips Representative for questions concerning this issue.
Quantity in commerce: 226 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Chile, Denmark , Estonia, Finland, France, Germany ,Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan, United Kingdom, and Utd. Arab. Emir.
Product codes and lots: Software R2.1 L 1 SP2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1942-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1942-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-05

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)