Z-0178-05

HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system)

Name: Z-0178-05 HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system)
Creator: Philips Ultrasound, Inc.
Published: 2004-09-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2004-09-10 / Terminated

FDA source

Philips Ultrasound, Inc. began a recall of HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system) on 2004-09-10. The reason FDA records is "Potential for device to cause burning of the skin". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0178-05
Status: Terminated
Initiated: 2004-09-10
Posted: 2004-11-05
Terminated: 2006-02-09
Recalling firm: Philips North America LLC
Product: HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system).
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Potential for device to cause burning of the skin.
FDA root cause: Other
Action: On 9/6/04 the firm sent a certified return receipt letter to customers advising of the issue and informing that a service representative will visit to install new software to reduce thermal output.
Quantity in commerce: 333 domestic units, 29 demos, 704 international units
Distribution: Units were distributed to medial facilities, hospitals, and veterinarians worldwide. Countries include Africa, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Domican Republic, Ecuador, France, Germany, Greece, Guam, Guatemala, Hungary, India, Israel, Italy, Jordan, Kuwait, Martinique, Mexico, Netherlands, New Zealand, Norway, Phlippines, Portugal, Puerto Rico, Peru, Santa Domingo, Saudia Arabia, Selangor, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, Zenica
Product codes and lots: Part # 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01) Site numbers: A42000896, A3B000796, A34000603, A2C000441, A32000483, A33000540, A28000273, A35000637, A35000649, A26000159, A45001061, A28000241, A37000732, A25000143, A35000663, A42000932, A32000505, A42000898, A33000546, A24000084, A26000165, A28000255, A28000266, A28000276, A45001050, A36000692, A45001066, A34000559, A24000052, A32000501, A2C000460, A3C000853, A34000582, A2A000350, A2C000458, A2B000408, A28000277, A27000197, A25000136, A33000550, A34000596, A24000104, A34000621, A33000549, A2B000374, A34000607, A43001003, A28000238, A34000568, A28000275, A36000674, A29000323, A2A000354, A29000318, A29000325, A27000188, A36000678, A28000253, A34000628, A27000204, A3B000804, A36000687, A3C000825, A25000140, A3B000799, A28000267, A2A000335, A2A000353, A31000489, A29000289, A2A000338, A39000780, A26000153, A35000636, A2A000348, A38000760, A42000916, A2B000395, A42000912, A24000101, A36000706, A35000665, A34000629, A42000907, A43001005, A25000131, A27000189, A25000123, A42000889, A2C000438, A2B000420, A28000231, A26000160, A37000735, A32000502, A34000595, A24000067, A42000885, A28000270, A24000054, A2B000358, A39000776, A2C000448, A3C000846, A24000087, A35000659, A2C000455, A39000769, A43001006, A26000161, A24000057, A42000945, A34000589, A37000723, A31000477, A31000488, A2B000411, A2C000440, A2C000452, A2C000456, A31000466, A31000467, A31000479, A31000480, A31000481, A32000509, A26000154, A27000181, A42000925, A33000523, A34000577, A3C000812, A29000290, A31000474, A34000602, A26000157, A2A000349, A42000901, A42000947, A23000047, A36000702, A25000146, A2A000345, A44001022, A28000280, A2C000449, A3C000850, A41000861, A24000060, A2A000330, A42000895, A27000212, A26000170, A27000192, A42000931, A37000738, A26000173, A26000179, A26000178, A29000300, A38000753, A39000783, A24000061, A2A000327, A27000186, A2C000463, A31000478, A2C000446, A31000492, A28000235, A28000229, A25000144, A2B000399, A27000198, A27000202, A2C000445, A34000588, A36000677, A3C000824, A43000982, A2B000365, A36000707, EMO00005, A36000705, 34000623, A26000176, A26000180, A25000106, A25000108, A25000115, A34000565, A34000578, A31000476, A32000504, A36000670, A2B000385, A3B000794, A2A000344, A36000694, A3B000806, A3C000826, A39000767, A42000899, A2C000437, A21000016, A25000118, A2C000444, A38000756, A37000720, A45001058, A37000721, A34000612, A32000490, A28000226, A28000260, A24000077, A25000111, A31000475, A33000534, A24000076, A25000116, A35000652, A31000470, A36000716, A35000630, A44001032, A41000872, A2C000451, A2C000457, A32000498, A29000319, A27000210, A24000051, A31000468, A34000557, A34000567, A3B000802, A42000934, A42000921, A35000650, A27000203, A23000040, A34000563, A21000018, A32000495, A36000717, A39000778, A24000096, A25000126, A26000164, A27000194, A42000893, A42000903, A32000515, A34000615, A34000616, A2C000439, A33000536, A34000587, A34000606, A32000507, A25000137, A24000056, A34000614, A25000133, A44001045, A25000147, A23000042, A35000664, A25000130, A25000148, A32000516, A34000611, A43000995, A37000736, A42000894, A31000482, A2A000331, A32000499, A43000980, A35000654, A44001019, A25000110, A34000556, A35000641, A35000642, A44001027, A44001028, A42000913, A3C000813, A42000928, A45001051, A2B000381, A2B000372, A2C000450, A32000513, A24000073, A3B000790, A34000597, A25000145, A31000493, A28000220, A34000627, A35000669, A28000265, A37000743, A35000645, A27000200, A29000310, A28000247, A26000171, A42000922, A27000184, A34000560, A28000243, A24000055, A35000644, A29000292, A21000015, A33000528, A32000517, A27000211, A28000257, A28000230, A2A000340, A34000599, A28000262, A2C000443, A2C000465, A35000643, A2A000337, A28000250, A31000491

Product code IYN

K002185Class IISonoace Sa 9900 Diagnostic Ultrasound SystemMedison America, Inc. / cleared 2000-08-01

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)