Recall of Philips L12-5 Ultrasound Transducer

Source: FDA · United States

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Philips Ultrasound, Inc. is voluntarily recalling 40 units of the Philips L12-5 Ultrasound Transducer to provide clarification on the device's useful life.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 9, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Philips Ultrasound, Inc. is conducting a voluntary recall to provide clarification and labeling that defines the useful life of the Philips L12-5 Ultrasound Transducer.

Which Products Are Affected

The affected products are 40 units of the Philips L12-5 Ultrasound Transducer. Model numbers include 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, and 989605420231. UDIs include (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, and (01)00884838067851(21)B1N1JB. Serial numbers include 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, and B1N1JB. The recall affects US nationwide distribution.

What You Should Do

Consumers should follow the initial firm notification, which was sent via letter, for instructions on this recall. Contact Philips Ultrasound, Inc. at their address: 1 Echo Dr, Reedsville, PA 17084-8603 for details on returns or further actions.

Why This Matters

This recall ensures that users have clear information on the useful life of the ultrasound transducers, which could help maintain proper device functionality and safety in medical settings.

Source

FDA Recall Number: Z-1620-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Philips Ultrasound, Inc. is voluntarily recalling 40 units of the Philips L12-5 Ultrasound Transducer to provide clarification on the device's useful life.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.