Philips IntelliSpace ECG System Recall Due to Inaccurate Patient Identifiers
Philips is recalling 11 IntelliSpace ECG Management Systems because imported Stress ECG records may contain inaccurate patient identifiers, posing a risk of misdiagnosis.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where the hazard is potential misdiagnosis and incorrect therapy, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Philips Medical Systems, Inc. is recalling 11 units of the IntelliSpace ECG Management System, Model No. 860426. This recall affects systems equipped with software option C61, which is used to import ECGs from the Quinton Stress ECG System.
The recall is issued because the systems have the potential to import Stress ECG records that contain multiple and inaccurate patient identifiers, including patient name, patient ID (PID), and Medical Record Number (MRN). This defect creates the potential for misdiagnosis and incorrect therapy.
The affected units were distributed worldwide, including in the United States (specifically California, Georgia, North Carolina, New Hampshire, New York, and Oregon), Canada, and Spain. Specific serial numbers for the affected units are listed in the official recall documentation.
The recalled product
- Product
- Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426
- Manufacturer
- Philips Medical Systems, Inc.
- Affected units
- 11
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 (11)
- Model No. 860426 Serial Numbers: US11400027
- US31400041
- US31400042
- US31400044
- US31400045
- US31400046
- US41400051
- US51300008
- US51400056
- US81300016
- USN1300020
Distribution
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