Covidien recalled 78 HealthCast Vital Sync Remote Patient Monitoring Systems sold worldwide, including in the United States. Alarms from the bedside monitor may not alarm or transmit to the remote system. Healthcare providers and patients should stop using the device immediately and await recall instructions.
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Covidien LLC or your healthcare provider for instructions. Notification method: Letter
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HealthCast Vital Sync is a remote patient monitoring system designed to route and store data from bedside monitors to an RPM platform, EMR, and CIS. It supports clinicians in real-time patient data review.
A failure in alarm transmission could delay medical staff response to patient status, creating safety risks for monitored patients.
This recall is not described as part of a broader industry pattern.
The recall poses a potential safety risk for patients who rely on real-time alarms to trigger clinical interventions. It may require healthcare facilities to halt use until remediation is confirmed and replacements issued.
On labeling, packaging, and the recall notice issued by Covidien. The FDA recall page also lists affected models and UDIs.
Remedy processing timelines are provided in the recall notification. Consumers should expect 4-8 weeks for refunds or replacements where offered.
Document all communications, store recall notices, capture photos of labels and UDI-DI codes, retain receipts and purchase records.
Product Numbers: VSLBASE03P / VITALSYNCSW03 and VSLBASE04P / VITALSYNCSW04 UDI-DI codes and serials: - Vital Sync 3.3.1 — 10884521844933 - Vital Sync 3.4.0 — 10884521844940 - Vital Sync 3.4.1 (OUS only) — 10884521847569 - Vital Sync 3.4.2 — 10884521856127 - Vital Sync 4.0.1 — 10884521849358 - Vital Sync 4.0.2 — 10884521856134 Models/CFN: VSLBASE03P / VITALSYNCSW03 Serials correspond to the versioned releases listed above Quantity recalled: 78 systems Distribution: Worldwide, including AK, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, MS, NC, NY, OH, OK, OR, SC, TN, TX, VA; also Spain.
No injuries or incidents have been reported.
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