Device recall: MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10
FDA enforcement event 79547 is a device recall by an individual recalling firm (name withheld) of Sesto Fiorentino, N/A, initiated 3 Jan 2018 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 30 May 2019. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), Sesto Fiorentino, N/A, Italy. FDA names an individual as the recalling firm; this site does not publish people's names.
Reason for recall
"The ultrasound system used in certain settings may result in overheating of the ultrasound probe head."
Distribution
"US distribution in the states: AZ, FL, OK, PA, and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1137-2018 | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 | 1 | Class II | Terminated | 28 Mar 2018 |
| Z-1138-2018 | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, CA541, EC1123, EC123, IH 618, IOT332, IOT342, L 415, LA332E, LA435, LA523, LA533, SI2C41, SL2325, TRT33 | 5 | Class II | Terminated | 28 Mar 2018 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The ultrasound system used in certain settings may result in overheating of the ultrasound probe head."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution in the states: AZ, FL, OK, PA, and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 May 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.