Z-1620-2026Class III
Philips L12-5 Ultrasound Transducer
Philips North America LLC / initiated 2025-09-05 / Open, Classified / root cause: design
Philips Ultrasound, Inc began a recall of Philips L12-5 Ultrasound Transducer on . FDA classified it as Class III and gives the reason as "To provide clarification and labelling to define the useful life of ultrasound transducers in the field". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1620-2026
- Classification
- Class III
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- Philips L12-5 Ultrasound Transducer
- Product code
- ITX Transducer, Ultrasonic, Diagnostic
- Reason for recall
- To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- An URGENT Medical Device Correction Notice, dated 8/19/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.
- Quantity in commerce
- 40 units
- Distribution
- US Nationwide distribution.
- Product codes and lots
- Model No. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231; UDI: (01)00884838067851(21)B27H7T, (01)00884838067974(21)B0B0B1, (01)00884838067851(21)B16RRG, (01)00884838067974(21)B0HWBM, (01)00884838067974(21)B0B39M, (01)00884838067851(21)B1N2FG, (01)00884838067851(21)B1DD6B, (01)00884838067851(21)B27GVB, (01)00884838067851(21)B27RQ7, (01)00884838067851(21)B1WT18, (01)00884838067851(21)B1N1JB; Serial No. B107H4, B106RJ, B02RKJ, B0PXC9, B03JZF, B107JF, B27H7T, B0B0B1, B106XL, B10CF6, B14HHX, B10BZF, B04PTM, B16RRG, 0392R5, B1JPC9, B1JQ8W, B0HWBM, B0B39M, B0XK56, B16L5T, B10BQ3, B0J9Q6, B106DF, B105C1, B1N2FG, B10CTM, B01QKF, B10C67, B0FD7B, B0M21H, B0P7ZP, B1DD6B, B0F6F2, B27GVB, B27RQ7, B14CBD, B14J0X, B1WT18, B1N1JB.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1618-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1619-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1620-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1621-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1622-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1623-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1624-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1625-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1626-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1627-2026 | Class III | Ongoing | Voluntary: Firm initiated | ||
| Z-1628-2026 | Class III | Ongoing | Voluntary: Firm initiated |
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