Vital Sync" VPMP & IM recall
Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
Why was Vital Sync" VPMP & IM recalled?
Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model # 10007101; Lot # 14A0041IN
- Product
- Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
- Recalling firm
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Quantity
- 3
- Distribution
- US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX.
- Recall date
- August 20, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)