Class 2 Device Recall Tablo Hemodialysis System

• Date Initiated by Firm: January 24, 2023
• Date Posted: April 07, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1351-2023
• Recall Event ID: 91844
• 510(K)Number: K190793 K211370
• Product Classification: Subsystem, water purification - Product Code FIP
• Product: Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.
• Code Information: Model Numbers: PN-0006000 PN-0007001 UDI-DI Code: 00850001011204 Serial Numbers for PN-00060000 600102M 600185M 600226M 600229M 600241M 600251M 600307M 600383M 600430M 600554M 600668M 600684M 600741M 600742M 600747M 600757M 600774M 600815M 600816M 600817M 600826M 600828M 600829M 600856M 600858M 600867M 600869M 600875M 600899M 600904M 600925M 600932M 600947M 600954M 600964M 600974M 600981M 600983M 600987M 600988M 601051M 601052M 601053M 601055M 601061M 601069M 601071M 601073M 601074M 601078M 601079M 601083M 601087M 601091M 601092M 601093M 601094M 601097M 601101M 601103M 601104M 601106M 601111M 601112M 601113M 601118M 601119M 601120M 601124M 601125M 601126M 601127M 601128M 601129M 601130M 601131M 601132M 601135M 601136M 601137M 601138M 601139M 601140M 601141M 601142M 601143M 601144M 601145M 601146M 601147M 601148M 601149M 601150M 601151M 601152M 601155M 601156M 601157M 601158M 601159M 601160M 601161M 601162M 601164M 601166M 601167M 601169M 601171M 601172M 601173M 601174M 601175M 601176M 601177M 601178M 601179M 601180M 601182M 601185M 601186M 601187M 601190M 601192M 601193M 601194M 601195M 601196M 601197M 601198M 601199M 601200M 601201M 601202M 601203M 601204M 601206M 601207M 601209M 601210M 601211M 601212M 601213M 601214M 601215M 601216M 601217M 601218M 601219M 601221M 601222M 601223M 601224M 601226M 601227M 601230M 601231M 601232M 601233M 601234M 601235M 601236M 601237M 601238M 601241M 601243M 601245M 601246M 601247M 601250M 601251M 601252M 601254M 601255M 601256M 601257M 601258M 601259M 601260M 601265M 601266M 601267M 601268M 601269M 601270M 601271M 601272M 601273M 601274M 601276M 601277M 601280M 601281M 601282M 601284M 601285M 601286M 601287M 601288M 601290M 601291M 601292M 601293M 601294M 601296M 601298M 601299M 601300M 601304M 601307M 601310M 601313M 601320M 601322M 601323M 601325M 601327M 601329M 601330M 601331M 601332M 601333M 601334M 601335M 601348M 601349M 601352M 601356M 601358M 601359M 601362M 601366M 601367M 601375M 601376M 601382M 601386M 601387M 601391M 601392M 601398M 601404M 601417M 601420M 601421M 601424M 601426M 601427M 601428M 601429M 601430M 601431M 601432M 601433M 601434M 601435M 601436M 601437M 601438M 601441M 601442M 601443M 601444M 601447M 601449M 601450M 601455M 601456M 601457M 601461M 601462M 601465M 601467M 601468M 601469M 601479M 601480M 601481M 601482M 601485M 601486M 601487M 601488M 601489M 601491M 601492M 601493M 601495M 601496M 601497M 601498M 601499M 601500M 601501M 601502M 601503M 601504M 601505M 601506M 601507M 601508M 601509M 601510M 601512M 601513M 601514M 601517M 601518M 601519M 601522M 601523M 601527M 601528M 601529M 601530M 601532M 601533M 601534M 601535M 601536M 601538M 601539M 601540M 601542M 601544M 601547M 601548M 601551M 601552M 601553M 601554M 601555M 601556M 601557M 601558M 601560M 601561M 601566M 601567M 601568M 601570M 601573M 601574M 601575M 601583M 601592M 601596M 601606M 601613M 601615M 601616M 601618M 601623M Serial Numbers for PN-0007001: 601098M 601099M 601107M 601108M 601110M 601115M 601116M 601117M 601184M 601188M 601189M 601301M 601303M 601306M 601309M 601351M 601572M 601576M 601577M 601584M 601585M 601591M
• Recalling Firm/ Manufacturer: Outset Medical, Inc.; 3052 Orchard Dr; San Jose CA 95134-2011
• For Additional Information Contact: Jennifer Sipple; 669-231-8200
• Manufacturer Reason for Recall: An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.
• FDA Determined Cause: Process control
• Action: On 01/24/2023, the firm communicated an "MEDICAL DEVICE FIELD ACTION" Letter via FedEx Standard Overnight to customers informing them that Outset Medical has identified that Tablo Hemodialysis Systems manufactured between May 2021 and February 2022 require recalibration of the conductivity sensor, due to the dialysate conductivity sensor giving potentially false trigger alarms such as Alarm_Dialysate_Conductivity_High or Dialysate Conductivity Error. In addition, in devices where recalibration is needed and isolated only to treatments where the prescribed sodium is less than or equal to 133mEq/L, there may be an unlikely occurrence of delivered dialysate sodium falling outside of listed device specifications. In these remote cases, the need for clinical intervention is not expected. Actions to be taken by Customer/user: " Outset Medical has assessed the risk of this issue and customer's Tablo device can continue to be used until serviced. " Outset request that customers complete the enclosed acknowledgment form and promptly return it to Outset Medical. " Disseminate this information to appropriate personnel within the customer's facility for processing and distribution. Actions to be taken by Outset: -Firm will recalibrate the conductivity sensor as part of routine maintenance or at the next service call. An Outset Field Service Engineer will coordinate the completion of the recalibration with your staff to minimize downtime of your Tablo system(s). Any questions, contact Outset Customer Experience team at 844-MYTABLO or 844-698-2256.
• Quantity in Commerce: 374 systems
• Distribution: U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI. O.U.S.: Not provided.
• 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 = FIP