Philips Xcelera Connect Software Recalled for Incomplete Data Exchange
Philips Healthcare is recalling 226 units of Xcelera Connect software because unformatted reports may result in incomplete information arriving at the interface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incomplete data exchange rather than a direct physical injury or life-threatening malfunction, fitting the criteria for a moderate severity issue where the risk is primarily operational or informational.
Plain-English summary
Philips Healthcare Inc. is recalling 226 units of Xcelera Connect, Software R2.1 L 1 SP2. This software serves as an interface engine for data exchange between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS, and Xcelera Cath Lab Manager (CLM). The data exchanged consists of demographic patient information, schedules, textual information, and text reports.
The recall was initiated because incomplete information may arrive from the unformatted reports interface. The affected software was distributed worldwide, including the United States and various international locations such as 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 the United Arab Emirates.
Healthcare facilities using this software should contact Philips Healthcare Inc. for further instructions on how to address the data exchange issue.
The recalled product
- 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…
- Manufacturer
- Philips Healthcare Inc.
- Category
- Medical Device — Software
- Affected units
- 226
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software R2.1 L 1 SP2
Distribution
Distributed nationwide across the United States.
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