CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

Ultrasound Transducer recalled by Hitachi Medical Systems

Hitachi Medical Systems America is recalling Ultrasound Transducer, distributed in 21 states. The recall was initiated on 20 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes17 21 32 37 38 39 41 43 45 46 48 57 58 59 61 63 64 69 73 77 78 81 82 86 87 92 96 97 99 107 108 109 114 115 116 118 120 121 122 126 129 130 132 135 139 140 141 143 144 147 148 151 155

Quantity recalled55

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0816-2018
FDA event ID: 79160
Recalling firm: Hitachi Medical Systems America, Twinsburg, OH
Classification: Class II
Status: Terminated
Recall initiated: 20 Oct 2017
FDA classified: 1 Mar 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

20 Oct 2017	Recall initiated by company
1 Mar 2018	Classified by FDA	+132 days
7 Mar 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The ultrasound probe may not have adequate protection against electrical shock hazards.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.

Where it was distributed

Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.

Arkansas Arizona California Colorado Florida Georgia Iowa Illinois Indiana Massachusetts Missouri North Carolina New York Oklahoma Oregon Pennsylvania South Carolina Texas Virginia Washington

Stores named: Walmart

Questions about this recall

Is Ultrasound Transducer recalled?

Yes. Hitachi Medical Systems America recalled Ultrasound Transducer on 20 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0816-2018.

Why was it recalled?

The ultrasound probe may not have adequate protection against electrical shock hazards.

Which lots are affected?

17 21 32 37 38 39 41 43 45 46 48 57 58 59 61 63 64 69 73 77 78 81 82 86 87 92 96 97 99 107 108 109 114 115 116 118 120 121 122 126 129 130 132 135 139 140 141 143 144 147 148 151 155

Where was it sold?

Distributed in 21 states: AR, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NY, OK, OR, PA, SC, TX, VA, WA, WV.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Hitachi Medical Systems America

All 17

Reported	Class	Recall	Company	Reason	Where
31 Mar 2021Device	CLASS II	Ultrasonic pulsed doppler imaging system recalled	Hitachi Medical Systems America	Potency & Assay	Nationwide
26 Feb 2020Device	CLASS II	UST-2265-2 Probe recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Other	8 states
13 Nov 2019Device	CLASS II	Hitachi Scenaria Whole-body X-ray CT System recalled	Hitachi Medical Systems America	Device Malfunction	16 states
29 Aug 2018Device	CLASS II	Hitachi Scenaria CT system recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Device Malfunction	TX
25 Jul 2018Device	CLASS II	Hitachi Oasis MRI system recalled by Hitachi Medical Systems	Hitachi Medical Systems America	Foreign Material	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide