Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 15 V4/Masimo Rainbow Sensors

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall LIFEPAK 15 V4/Masimo Rainbow Sensorssee related information
Date Initiated by FirmJanuary 21, 2025
Date PostedFebruary 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1184-2025
Recall Event ID 95766
PMA NumberP160026 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductLIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo LNCS-II rainbow DCI 8 SpCO, Adult Reusable Sensor REF 11996-000519 Masimo LNCS-II rainbow DCI 8 SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow" 8 SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), and methemoglobin saturation (SpMet) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Code Information Catalog Number: 11996-000515 UDI-DI/GTIN code: 00843997010863 Lot Number: 23G79 Catalog Number: 11996-000519 UDI-DI/GTIN code: 00843997015608 Lot Numbers: 23HER 23HPT 23JBN 23JTA Catalog Number: 11996-000520 UDI-DI/GTIN code: 00843997015615 Lot Numbers: 23HNV 23JBP
FEI Number 3015876
Recalling Firm/
Manufacturer		 Physio-Control, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information ContactJoyce Staggs
425-867-4597
Manufacturer Reason
for Recall		Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
FDA Determined
Cause 2		Device Design
ActionOn 1/21/2025, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS 2-Day mail to customers to inform them that the LIFEPAK 15 V4 displays an error where "SpO2: Sensor does not support SpCO or SpMET". The error results in preventing users from utilizing LIFEPAK 15 V4 SpCO and SpMet functionalities when connected to specific lots of Masimo Rainbow Sensors. Customers are instructed to: 1. Immediately check your internal inventory to locate the product listed on the attached business reply form and remove them from their point of use. 2. Return the enclosed business reply form by email to RSRecall@Stryker.com to confirm receipt of this notification. 3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return and replacement of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. Please keep this communication close to the affected items until replacement. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients appropriately. For questions or concerns - contact Customer Service +1 800 787 9537, option 2, from 8:00 AM to 7:00 PM (Eastern Time), Monday Friday or by email at medtechsup@stryker.com.
Quantity in Commerce622
DistributionU.S. Nationwide distribution including in the states of CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MO, MS, NC, NH, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WV.
Total Product Life CycleTPLC 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.
PMA DatabasePMAs with Product Code = MKJ
-
-