CLASS I ONGOING Device recall · Reported 27 Sep 2023 · FDA Enforcement Report
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part recalled
Hamilton Medical is recalling Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for, distributed nationwide in the US. The recall was initiated on 26 Jul 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2530-2023
- FDA event ID
- 92873
- Recalling firm
- Hamilton Medical, Reno, NV
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 26 Jul 2023
- FDA classified
- 20 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- CPAP & Ventilators
Timeline
| 26 Jul 2023 | Recall initiated by company | |
| 20 Sep 2023 | Classified by FDA | +56 days |
| 27 Sep 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator
Where it was distributed
Distribution US nationwide, including Puerto Rico. OUS: Not provided
Questions about this recall
Is Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for recalled?
Yes. Hamilton Medical recalled Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for on 26 Jul 2023. The recall is Class I and its status is Ongoing. Recall number Z-2530-2023.
Why was it recalled?
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose function and lead to interruption of ventilation.
Which lots are affected?
UDI: 07630002800761 / Affected Serial Numbers: 4050193, 4050210, 4050194 and 4016669
Where was it sold?
Distribution US nationwide, including Puerto Rico. OUS: Not provided
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hamilton Medical
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Hamilton-T1, REF: 161009, Intensive Care and Transport Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-C1, REF: 161001, Portable Intensive Care Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-MR1, REF: 161010, Intensive Care Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton-T1, REF: 161006, Intensive Care and Transport Ventilator recalled | Hamilton Medical | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Hamilton C1/T1/MR1 recalled by Hamilton Medical | Hamilton Medical | Lead & Heavy Metals | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |