Food, drugs, devices › Nellcor Puritan Bennett Inc. (dba Covidien LP)
Device recall: Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packag
FDA enforcement event 68802 is a device recall by Nellcor Puritan Bennett Inc. (dba Covidien LP) of Boulder, CO, initiated 17 Jul 2014 and classified Class II, with 2 product records.
FDA defines Class II as 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. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 21 Oct 2014. Initiation: voluntary: firm initiated. Nellcor Puritan Bennett Inc. (dba Covidien LP) has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO.
Reason for recall
"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."
Distribution
"US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2234-2014 | 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… | 3 | Class II | Terminated | 20 Aug 2014 |
| Z-2235-2014 | Vital Sync RMS 1.0 when loaded with v2.4 software, 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… | 9 | Class II | Terminated | 20 Aug 2014 |
Context
Other enforcement events for Nellcor Puritan Bennett Inc. (dba Covidien LP)
All 9 events for Nellcor Puritan Bennett Inc. (dba Covidien LP)
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to states of: LA, IL, MS, CO, IN, GA, CA and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.