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 3 Device Recall BP105ec

  • 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 3 Device Recall BP105ecsee related information
Date Initiated by FirmJuly 03, 2025
Date PostedAugust 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2349-2025
Recall Event ID 97217
510(K)NumberK081661 K160807 K163120 K172607 K181485 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductBP10-5ec Transducer Probe
Code Information Model No. 989605395642; UDI: (01)00884838061552(21)B29VPV, (01)00884838061552(21)B29VQ6, (01)00884838061552(21)B2CYJ4, (01)00884838061552(21)F06M63, (01)00884838061552(21)F06QYR, (01)00884838061552(21)B2CY7P, (01)00884838061552(21)F058R4, (01)00884838061552(21)B2CY8T, (01)00884838061552(21)F05YF6, (01)00884838061552(21)F0628C, (01)00884838061552(21)B29VPW, (01)00884838061552(21)F064N9, (01)00884838061552(21)F078HF, (01)00884838061552(21)F05Y6Y, (01)00884838061552(21)B2CYJJ, (01)00884838061552(21)B2CYD7; Serial No. B29VPV, B29VQ6, B2CYJ4, F06M63, F06QYR, B2CY7P, F058R4, B2CY8T, F05YF6, F0628C, B29VPW, F064N9, F078HF, F05Y6Y, B2CYJJ, B2CYD7.
Recalling Firm/
Manufacturer		 Philips Ultrasound, Inc
1 Echo Dr
Reedsville PA 17084-8603
For Additional Information ContactPhilips Customer Care Solutions Center
1-800-722-9377
Manufacturer Reason
for Recall		To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
FDA Determined
Cause 2		Device Design
ActionAn URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.
Quantity in Commerce171,322 units
DistributionUS Nationwide distribution.
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.
510(K) Database510(K)s with Product Code = IYN
510(K)s with Product Code = IYN
-
-