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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC

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 Class 2 Device Recall Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSCsee related information
Date Initiated by FirmJanuary 09, 2024
Date PostedApril 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1732-2024
Recall Event ID 93883
510(K)NumberK182868 
Product Classification Oximeter, tissue saturation - Product Code MUD
ProductMedtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
Code Information Lot # 2023-02-22, 2023-04-28, 2023-05-04, 2023-07-20; UDI: 10884521780125
FEI Number 2936999
Recalling Firm/
Manufacturer		 Covidien
6135 Gunbarrel Ave
Boulder CO 80301-3214
For Additional Information ContactMedtronic Customer Service
1800-962-9888
Manufacturer Reason
for Recall		manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
FDA Determined
Cause 2		Process design
ActionOn January 9, 2024 Medtronic (parent company of Covidien) issued a Urgent Medical Device Recall notification via UPS. Medtronic asked consignees to take the following action: 1. Quarantine and stop using all product from the affected lots of INVOS" Reusable Sensor Cables PMAC71RSC and PMAC71RIC. " See attachment A for guidance on how to identify affected devices via cable box packaging or cable hang tag. 2. Complete and return Customer Confirmation Form. Complete and return the enclosed Customer Confirmation Form even if you do not have any affected lots remaining. 3. Reach out to Medtronic to obtain RGA # /Returned Goods Authorization number. " Your Medtronic Representative / Medtronic Customer Service at rs.covidienfeedbackcustomerservice@medtronic.com can assist in initiating product return as necessary. 4. Return all product from the affected lots in your possession to Medtronic as described on the Customer Confirmation Form. 5. Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lots has been transferred or distributed.
Quantity in Commerce2305 units
DistributionUS: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom
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 = MUD
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