Radius VSM ECG Pre-connected Set Recalled for Incorrect Heart Rate Detection
Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.
What this means for you
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: This is an FDA Class II recall of a medical device with the potential to delay treatment by masking or obscuring true positive alarms through false alarm generation. No illnesses or injuries are reported in the source text, but the hazard presents a risk of patient harm in a clinical setting where diagnostic accuracy is critical.
Plain-English summary
Masimo Corporation is recalling Radius VSM ECG pre-connected Sets (REF: 4842, 4695) distributed worldwide. The ECG electrode assembly may incorrectly detect extreme bradycardia, tachycardia, and trigger alarms on patients with normal heart rates. This false alarm capability may distract clinicians away from management of true positive alarms, which could delay appropriate treatment.
Additionally, the small and medium size blood pressure cuffs included in these sets may contain rough edges that could result in skin irritation or redness.
A total of 772 units were distributed across multiple US states (OK, CA, MD, MA, NY, UT, NC, TN, MN, TX, OH, PA, VA) and internationally to Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, and Paraguay.
Healthcare providers and patients should immediately stop using affected units and contact Masimo Corporation for device replacement or additional instructions.
The recalled product
- Product
- Radius VSM ECG pre-connected Set, REF: 4842, 4695
- Manufacturer
- Masimo Corporation
- Hazard
- false-alarm-detection
- skin-irritation
- misdiagnosis-risk
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 (12)
- REF/UDI-DI/Lot: 4842/10843997011003/25AJH
- 25KMA
- 25MSC 4695/10843997016015/24N17
- 25BBJ
- 25DMH
- 25FBR
- 24KLV
- 24N17
- 25AGZ
- 25D10
- 25GJM
- 25KBF
Distribution
Distributed nationwide across the United States.
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