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U.S. Department of Health and Human Services

Class 2 Device Recall EarlyVue VS30 Vitals Monitor

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  Class 2 Device Recall EarlyVue VS30 Vitals Monitor see related information
Date Initiated by Firm August 31, 2023
Date Posted September 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-2654-2023
Recall Event ID 93020
510(K)Number K190624  
Product Classification Alarm, blood-pressure - Product Code DSJ
Product EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 863380
Code Information UDI-DI: 00884838091412; Serial Numbers: DE72401360 DE72401393 DE72400231 DE72400232 DE72400235 DE72400254 DE72400237 DE72400238 DE72400239 DE72409250 DE72409240 DE72409249
Recalling Firm/
Manufacturer		 Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer Reason
for Recall		 A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated.
FDA Determined
Cause 2		 Software design
Action An URGENT Medical Device Correction notification letter dated 8/29/23 was sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users If you use EarlyVue VS30 devices with both options E01 (Oridion Microstream Sidestream etCO2) and option R21 (Masimo Rainbow RRa): 1) Observe the EarlyVue VS30 monitor display screen for out-of-limit acoustic respiration rates (RRa) during procedures when there is simultaneous use of E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa), while Respiration Source Mode is set to Auto, and the CO2 hardware module setting is switched to Standby. This notice should be passed on to all those who need to be aware within your organization or to any organization where EarlyVue VS30 with both options E01 (Oridion Microstream Sidestream etCO2) and option R21 (Masimo Rainbow RRa) devices have been transferred. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will perform software upgrade to your device. If you need any further information, please contact your local Philips representative, or call 1-800-722-9377.
Quantity in Commerce 13 total devices
Distribution Worldwide - US Nationwide distribution in the states of MA, MI. The country of Brazil.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSJ and Original Applicant = Philips Medizin Systeme Boeblingen GmbH
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