Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indi
FDA device recall Z-0019-2025 · posted 2024-10-03 · Open, Classified
Recall details
- Recalling firm
- Outset Medical, Inc.
- Reason for recall
- Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.
- Action taken
- On 8/1/24, field action notices were sent to customers who were asked to do the following: Component replacement will be performed with routine maintenance and/or service to affected devices. To support component replacement, the device software may be upgraded, as needed. A firm's Field Service Engineer will coordinate this service with your staff to minimize device downtime. Disseminate this information to appropriate personnel within your facility for processing and distribution. This notice should be shared with any organization where the potentially affected devices have been transferred. Identify and notify your home patients with affected devices of this component replacement. Accounts that have completed the firm's biomedical engineering training program and service their systems will receive additional information. Complete and return the response form via email to FieldActionAdvisory@OutsetMedical.com If you have any questions regarding this notification contact the firm's Technical Support team (844-698-2256 or support@outsetmedical.com).
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- KDI
- Quantity affected
- 2,422
- Distribution
- US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH, MI, WA, ID, TX, TN, WY, IA, LA, NE, IN, AR, NV, WV, CO, NJ, MD, KS, UT, CT, MN, MS, WI, HI, DE, VT, MT, OR, ND. OUS: UAE
- Date initiated
- 2024-08-01
- Date posted
- 2024-10-03
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tablo® Hemodialysis System (K233335) | Outset Medical, Inc. | 2023-12-05 |