Z-2167-2014Class II

Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging

Name: Z-2167-2014 Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Creator: Biosound Esaote, Inc.
Published: 2014-06-26
License: https://open.fda.gov/license/

Esaote North America, Inc / initiated 2014-06-26 / Terminated / root cause: software

FDA source

Biosound Esaote, Inc. began a recall of Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging on 2014-06-26. FDA classified it as Class II and gives the reason as "Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2167-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-26
Posted: 2014-08-08
Terminated: 2015-07-17
Recalling firm: Esaote North America, Inc
Product: Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Product code: JOP Transducer, Ultrasonic
Reason for recall: Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.
Root cause tag: software
FDA root cause: Software design
Action: On 06/26/2014, Esaote North America sent an advisory letter via FEDEX (with signature required) to each customer or consignee affected by this voluntary recall. The packet contained the advisory letter, including actions to be taken by the user, information about a pending software upgrade, and a business reply card to confirm they received the letter and have the equipment noted on the advisory letter. Customers with questions were instructed to call 800-428-7378. For questions regarding this recall call 1-317-813-6005
Quantity in commerce: 1,301 units
Distribution: Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV. International**Product was also shipped to consignees in Canada
Product codes and lots: Part #: 9600165000 PROBE, PA230E Serial #'s: 07011, 10005, 10007, 10010, 10011, 10012, 10013, 10015, 10017, 10021, 10042, 10068, 10070, 10079, 10085, 10086, 10087, 10088, 10089, 10092, 10101, 10102, 10117, 10139, 10149, 10154, 10155, 10169, 10170, 10176, 10177, 10179, 10183, 10184, 10194, 10203, 10205, 10217, 10238, 10246, 10247, 10284, 10285, 10286, 10294, 10300, 10301, 10303, 10305, 10306, 10313, 10314, 10318, 10482, 10533, 10534, 10539, 10548, 10559, 10560, 106, 10729, 10820, 10905, 10906, 10907, 10908, 10909, 10984, 1100, 11011, 11032, 11108, 11124, 11126, 11138, 11168, 11171, 11179, 11184, 11188, 11198, 11199, 11206, 11215, 11226, 11326, 11327, 11332, 11353, 11374, 1142, 1152, 1154, 1161, 1163, 1170, 11794, 11809, 11987, 12003, 12006, 12018, 12028, 12059, 12060, 12062, 12063, 12064, 12065, 12073, 12126, 12127, 12133, 12137, 12138, 12141, 12143, 12144, 12150, 12151, 12153, 12158, 12161, 12174, 12178, 12180, 12183, 12184, 12186, 12192, 12193, 1220, 12200, 12202, 12203, 12205, 12216, 12217, 12312, 12321, 12327, 12332, 12335, 1235, 12353, 12355, 12356, 12384, 12627, 12632, 12812, 12912, 1300, 13019, 13025, 13046, 13051, 13073, 13074, 13075, 13082, 13129, 13146, 13168, 13179, 13180, 13186, 13255, 13258, 13260, 13265, 13268, 13271, 13274, 13275, 13277, 13288, 13289, 13290, 13292, 13323, 13325, 13326, 13437, 13524, 13540, 13567, 13588, 13590, 13593, 13629, 139, 14083, 14085, 14088, 14203, 14204, 14317, 14318, 14319, 14328, 14329, 14331, 14333, 14347, 14541, 14545, 14547, 14548, 14784, 148, 14827, 14875, 14894, 14895, 14921, 14926, 14927, 14929, 14949, 14950, 14951, 14952, 14953, 14954, 14955, 14956, 14970, 14977, 14978, 15242, 15243, 15244, 15247, 15289, 15291, 15293, 15307, 15308, 15310, 15311, 15315, 1543, 15631, 15632, 15646, 15648, 15649, 15650, 15654, 15656, 15711, 15712, 15714, 15716, 15949, 1595, 15951, 15954, 15955, 15957, 15958, 15959, 1596, 15960, 15961, 15962, 1600, 16004, 16005, 16008, 16009, 16010, 16011, 16013, 16015, 16019, 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22408, 22460, 22465, 22469, 2247, 22470, 22471, 22475, 22477, 22481, 22483, 22488, 22489, 22490, 2255, 2268, 22738, 22739, 22740, 22741, 22742, 22823, 22824, 22825, 22826, 22828, 22872, 22873, 22875, 22876, 22878, 22880, 22890, 22939, 22945, 22956, 23014, 23015, 23043, 23044, 23048, 23049, 23050, 23089, 2323, 2377, 2418, 2419, 2424, 2426, 2431, 2433, 2445, 2469, 2491, 2493, 2494, 2504, 2517, 2518, 2523, 2532, 2536, 254, 2549, 2595, 2599, 2602, 2606, 263, 2985, 3030, 3031, 3055, 3056, 3119, 3121, 3126, 3139, 3236, 3241, 3360, 3365, 3484, 3508, 3509, 3510, 3515, 3534, 3535, 3536, 3540, 3587, 3588, 3593, 3608, 3636, 3640, 3642, 3645, 3651, 3653, 3691, 374, 3743, 375, 3750, 3751, 3754, 3762, 3765, 3773, 3776, 3777, 3778, 3779, 3789, 3790, 3802, 3804, 3806, 3811, 3813, 3814, 3817, 3832, 3844, 3846, 3848, 3895, 3896, 3897, 3899, 3900, 3925, 3926, 3927, 3928, 3930, 3931, 3933, 3935, 3936, 3937, 3938, 3940, 3942, 3948, 3951, 3964, 3998, 4021, 4022, 4045, 410, 4185, 4186, 4188, 4193, 4203, 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8346, 8396, 8436, 8443, 8496, 8498, 8507, 8508, 8510, 8511, 8514, 8515, 8516, 8529, 853, 8541, 8545, 8550, 862, 8836, 884, 890, 8956, 9003, 9022, 9054, 9058, 9063, 9076, 9079, 9083, 9085, 9112, 9178, 9185, 9191, 9193, 9194, 9209, 9240, 9244, 9250, 9266, 9267, 9271, 9272, 9273, 9274, 9278, 9279, 9282, 9286, 9289, 9290, 9291, 9394, 9398, 9401, 9404, 9405, 9406, 9409, 9415, 9419, 9424, 9426, 944, 9468, 9480, 9483, 9484, 9485, 9486, 9487, 9495, 9505, 9515, 96, 9600165000S, 9683, 97, 979, 9824, 983, 9836, 9874, 9889, 9890, 9912, 9934, 9935, 9943, 9944, 9945, 9956, 9957, 9969, 9972, 9975, 9992, 9994 & 9997. Part #: 97154411675 PROBE, PA230E Serial #'s: 13373, 13550, 13754, 13764, 13767, 13776, 13778, 13790, 13803, 13836, 13842, 13856, 13965, 13996, 14006, 14018, 14710, 14982, 15001, 15005, 15021, 15022, 15033, 15037, 15039, 15059, 15166, 15179, 15181, 15184, 15185, 15483, 15484, 15670, 15731, 15751, 16689, 16694, 16798, 16799, 16807, 16816, 16817, 16819, 18024, 18037, 18059, 18085, 18089, 18635, 18653, 18654, 18656, 18657, 18659, 18667, 18677, 18943, 18944, 18948, 18949, 18950, 18953, 18956, 18959, 18960, 18962, 18963, 18965, 18991, 18996, 18997, 19008, 19012, 19017, 19019, 19250, 19251, 19252, 19253, 19255, 19256, 19259, 19260, 19261, 19262, 19263, 19295, 19520, 19522, 19530, 19531, 19714, 19734, 19739, 19904, 19914, 19921, 19926, 19931, 19933, 19998, 20493, 20494, 20529, 20550, 20555, 20557, 20566, 20568, 20570, 20573, 20575, 20576, 20585, 20588, 20589, 20787, 20851, 20854, 20874, 20883, 20885, 20894, 20900, 20908, 20909, 20933, 20935, 20938, 20941 & 20948.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2167-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2167-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-08

Product code JOP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)