St Jude Medical Inc. Recall: Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 1000
St Jude Medical Inc. Recall: Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 1000 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: St Jude Medical Inc.; Product: Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 1000
| Recalling firm | St Jude Medical Inc. |
|---|---|
| Product | Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933 |
| Reason for recall | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | U.S. Nationwide distribution |
| Recall initiated | 20180416 |
| Recall number | Z-2326-2018 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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