Stable Base T-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10861779000281), received between Dec 18, 2018 and Feb 23, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Insufficient Device Problem Information

  ON FEBRUARY 03RD, 2026, WE HAVE BEEN INFORMED ABOUT 7 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH BODYGUARDIAN MINI+ AND BODYGUARDIAN ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 7 REPORTS COVERING A PERIOD FROM OCTOBER 01ST, 2025 OCTOBER 11TH, 2025. NO MEDICAL INTERVENTION WAS NECESSARY FOR 6 INCIDENTS. FOR ONE INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. THE REPORTABLE EVENT HAS HAPPENED ON OCTOBER 01ST, 2025. IT WAS DISCLOSED THAT THE PATIENT'S SKIN WAS PREPARED USING SOAP AND WATER BEFORE APPLYING THE ECG ELECTRODES. THE PATIENT EXPERIENCED "REDNESS, ITCHING, RASH, PEELING SKIN ". THE ECG ELECTRODES REMOVAL HAS BEEN DISCLOSED AS "SOAP AND WATER PEELED, SELF DETACHMENT". THE INITIAL REPORT ALSO SPECIFIES THE INFORMATION: "THE ISSUE IS FOR SEVERE SKIN IRRITATION THAT RESULTED FROM A THIRD-PARTY ELECTRODE PRODUCT USED IN CONJUNCTION WITH THE MONITOR." IT WAS ALSO STATED THAT A MEDICAL INTERVENTION WAS NECESSARY BUT NO FURTHER INFORMATION WAS PROVIDED HOW IT WAS TREATED AFTERWARDS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Itching Sensation; Peeling; Rash

  MAUDE report 24413037 ↗
• InjuryJun 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MAY 06TH, 2025, WE HAVE BEEN INFORMED ABOUT 39 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH BODYGUARDIAN MINI+ AND BODYGUARDIAN ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 39 REPORTS COVERING A PERIOD FROM OCTOBER 21ST, 2024 TO MARCH 16TH, 2025. NO MEDICAL INTERVENTION WAS NECESSARY FOR 38 INCIDENTS. FOR ONE INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. THE REPORTABLE EVENT HAS HAPPENED ON FEBRUARY 05TH, 2025. IT WAS DISCLOSED THAT THE PATIENT'S SKIN WAS PREPARED USING SOAP AND WATER BEFORE APPLYING THE ECG ELECTRODES. THE PATIENT EXPERIENCED "REDNESS, ITCHING, RASH, OPEN SORES ". IT WAS REPORTED THAT THE ECG STUDY LASTED FOR 13 DAYS AND THE ECG ELECTRODES HAVE BEEN CHANGED DAILY. THE ECG ELECTRODES REMOVAL HAS BEEN DISCLOSED AS "GENTLY ROLLED DRY". THE INITIAL REPORT ALSO SPECIFIES THE INFORMATION: "PLACED BY EXISTING IRRITATION? NO". IT WAS ALSO STATED THAT A MEDICAL INTERVENTION WAS NECESSARY BUT NO FURTHER INFORMATION WAS PROVIDED HOW IT WAS TREATED AFTERWARDS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Itching Sensation; Peeling; Rash

  MAUDE report 22121591 ↗
• InjuryMar 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON FEBRUARY 20TH, 2024, WE HAVE BEEN INFORMED ABOUT 23 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL: SBW601 AND SBT601) HAD BEEN USED WITH BODYGUARDIAN MINI+ AND BODYGUARDIAN ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 23 REPORTS COVERING A PERIOD FROM AUGUST 15TH - NOVEMBER 03RD. NO MEDICAL INTERVENTION WAS NECESSARY FOR 22 INCIDENTS. FOR ONE INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. THE REPORTABLE EVENT DISCLOSED THAT THE PATIENT'S SKIN WAS PREPARED USING SALINE WIPES, SOAP AND WATER BEFORE APPLYING THE ECG ELECTRODES. THE PATIENT EXPERIENCED "REDNESS, ITCHING, RASH, BLISTERS, BURNING SENSATION ON SKIN, PEELING SKIN, BURNT SKIN, BLEEDING, OPEN SORES". IT WAS REPORTED THAT THE ECG ELECTRODES PEELED WHEN BATHING. IT WAS STATED THAT A MEDICAL INTERVENTION WITH HYDROCORTISONE CREAM USP 2.5 WAS USED TO TREAT THE INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Peeling; Rash; Skin Burning Sensation

  MAUDE report 18892570 ↗
• InjuryNov 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6), 2023, WE HAVE BEEN INFORMED ABOUT 25 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH BODYGUARDIAN MINI+ AND BODYGUARDIAN ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 25 REPORTS COVERING A PERIOD FROM (B)(6). NO MEDICAL INTERVENTION WAS NECESSARY FOR 24 INCIDENTS. FOR 1 INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. THE REPORTABLE EVENT DISCLOSED THAT THE PATIENT'S SKIN WAS PREPAED USING SOAP AND WATER BEFORE APPLYING THE ECG ELECTRODES. THE PATIENT EXPERIENCED "REDNESS, ITCHING, RASH, WELT, BURNING SENSATION ON SKIN, PEELING SKIN". IT WAS REPORTED THAT THE ECG ELECTRODES HAVE BEEN REMOVED "ABRUPTLY PEELED DRY". IT WAS STATED THAT A MEDICAL INTERVENTION WITH HYDRCORTIZONE CREAM WAS USED TO TREAT THE INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Peeling; Rash; Skin Burning Sensation

  MAUDE report 18090975 ↗
• InjuryAug 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JULY 17TH, 2023, WE HAVE BEEN INFORMED ABOUT 29 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH BODYGUARDIAN MINI+ AND BODYGUARDIAN ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 29 REPORTS COVERING A PERIOD FROM MAY 05TH - JUNE 26TH. NO MEDICAL INTERVENTION WAS NECESSARY FOR 28 INCIDENTS. FOR 1 INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. THE REPORTABLE EVENT DISCLOSED THAT THE PATIENT'S SKIN WAS PREPERED USING SALINE WIPES, SOAP AND WATER BEFORE APPLYING THE ECG ELECTRODES. THE PATIENT EXPERIENCED "REDNESS, ITCHING, RASH, WELT, BURNING SENSATION ON SKIN, PEELING SKIN". THE ECG ELECTRODES HAVE BEEN REMOVED "WHILE BATHING PEELED, SELF DETACHMENT". IT WAS STATED THAT A MEDICAL INTERVENTION WITH ANTI BIOTIC CREAM WAS USED TO TREAT THE INJURY AND THAT "THE PATIENT DECIDED TO STOP THE STUDY AFTER APPROXIMATELY 14 DAYS OF WEAR DUE TO SKIN IRRITATION". NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Peeling; Rash; Skin Burning Sensation

  MAUDE report 17440921 ↗
• InjuryJun 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MAY 11TH, 2023, WE HAVE BEEN INFORMED ABOUT 158 COMPLAINTS WITH ECG ELECTRODES COLLECTED BY PHILIPS OVER A PERIOD FROM 2021 TILL 2023. MONITORING ECG ELECTRODES REFERENCE (B)(4) (OUR MODEL FSTB.C.A) AND MONITORING ECG ELECTRODES REFERENCE (B)(4) (OUR MODEL F55 ) HAD BEEN CONCERNED. REVIEWING THESE 158 COMPLAINTS WE HAD DETECTED THAT 7 COMPLAINTS CITE A SKIN INJURY. 5 COMPLAINTS HAVE BEEN LOGGED BY FEBRUARY 1ST, 2021 SPECYFING A SKIN INJURY HAPPENED IN THE US. IT WAS INITIALLY STATED THAT "OVER THE PAST 4-6 MONTHS, NSS HAS NOTED THAT THE ELECTRODES ARE MORE DIFFICULT TO REMOVE EVEN WITH THE USE OF REMOVE AND THEY HAD A COUPLE INSTANCES OF REMOVAL OF THE ELECTRODES CAUSED SKIN INJURY." CONCERNED MONITORING ECG ELECTRODES REFERENCE (B)(4) (OUR MODEL FSTB.C.A) LOT NUMBER: 200618-0419. 1 COMPLAINT HAS BEEN LOGGED BY MARCH 2ND, 2022 SPECYFING A SKIN INJURY HAPPENED IN CHINA. IT WAS INITIALLY STATED THAT "THE PATIENT WAS ADMITTED TO HOSPITAL FOR "REPEATED NAUSEA AND VOMITING FOR MORE THAN 4 HOURS AFTER TAKING ABOUT 80ML OF PRORATE," THE DOCTOR TO DO ECG MONITOR. AFTER CHECK THE PATIENT, THE DOCTOR FIND THE SKIN OF PATIENT ARE DAMAGED,ABOUT 1.5MM × 3.5MM, THE DOCTOR REPLACE THE ELECTROD

  Patient problems: Localized Skin Lesion; Skin Inflammation/ Irritation

  MAUDE report 17077978 ↗
• InjuryMay 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023 , WE HAVE BEEN INFORMED ABOUT 26 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH BODYGUARDIAN MINI+ AND BODYGUARDIAN ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 26 REPORTS COVERING A PERIOD FROM (B)(6) THRU (B)(6). NO MEDICAL INTERVENTION WAS NECESSARY FOR 25 INCIDENTS. FOR 1 INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. THE REPORTABLE EVENT DISCLOSED THAT THE PATIENT'S SKIN WAS PREPERED USING SALINE WIPES BEFORE APPLYING THE ECG ELECTRODES. THE PATIENT EXPERIENCED "REDNESS, PEELING SKIN, OPEN SORES". THE ECG ELECTRODES HAVE BEEN REMOVED "GENTLY ROLLED DRY". IT WAS ALSO REPORTED THAT THE PATIENT DECIDED TO PAUSE THE STUDY AND DECIDED THAT THEY WILL RECONNECT ONCE THE REPORTED SKIN IRRITATION HEALS. IT WAS STATED THAT A MEDICAL INTERVENTION WITH NEOSPORIN WAS USED TO TREAT THE INJURY AND THAT THE PATIENT DECIDED TO PAUSE THE STUDY AND DECIDED THAT THEY WILL RECONNECT ONCE THE REPORTED SKIN IRRITATION HEALS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blister

  MAUDE report 16858656 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH A VERITY ECG MONITOR. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 26 ACCOUNTS FROM NOVEMBER 2018 TO JANUARY 2019. SOME PATIENTS DISCONTINUED USE TO AWAITING HEALING OR MORE INFORMATION FROM PHYSICIAN AND OTHERS WERE SENT ELECTRODES THAT ARE MORE SENSITIVE, IF POSSIBLE, TO TRY." THE REPORT REFERRED TO 26 SEPARATE CASES, INVOLVING A TOTAL OF 4 DIFFERENT LOT/BATCHES OF ITEM T-601 (50814) AND 10 DIFFERENT LOT/BATCHES OF ITEM W-601 (50809). NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.

  Patient problems: Irritation

  MAUDE report 8518352 ↗
• InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6)2018, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH A VERITY ECG MONITOR. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 63 ACCOUNTS FROM MAY 2018 TO EARLY NOVEMBER 2018. THE ABOVE SUMMARY REPORT REFERRED TO 63 SEPARATE CASES, WHICH OCCURED BETWEEN (B)(6)2018, INVOLVING A TOTAL OF 10 DIFFERENT LOT/BATCHES OF ITEM T-601 (50814) AND 15 DIFFERENT LOT/BATCHES OF ITEM W-601 (50809). (...) SOME PATIENTS DISCONTINUED USE TO AWAITING HEALING OR MORE INFORMATION FROM PHYSICIAN AND OTHERS WERE SENT ELECTRODES THAT ARE MORE SENSITIVE, IF POSSIBLE, TO TRY. THESE ELECTRODES WERE USED WITH OUR VERITE DEVICE." NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.

  Patient problems: Irritation

  MAUDE report 8173015 ↗