Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-0696-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Ingenuity Core 128 728323

Product Classification:

Class II

Date Initiated: November 12, 2016

Date Posted: December 14, 2016

Recall Number: Z-0696-2017

Event ID: 75756

Reason for Recall:

Software error due to the filament on timer

Status: Terminated

Product Quantity: 509

Code Information:

30016, 30023, 30024, 30151, 32000, 32001, 32008, 32010, 32012, 32013, 32015, 32016, 32018, 32021, 32022, 32024, 32026, 32028, 32032, 32033, 32034, 32036, 32037, 32041, 32042, 32043, 32044, 32046, 32047, 32048, 32049, 32050, 32051, 32052, 32053, 32054, 32055, 32056, 32057, 32058, 32059, 32060, 32061, 32062, 32063, 32064, 32065, 32066, 32067, 32068, 32069, 32070, 32071, 32072, 32073, 32074, 32075, 32076, 32077, 32078, 32079, 32080, 32081, 32082, 32084, 32085, 32086, 32087, 32088, 32089, 32090, 32091, 32092, 32093, 32094, 32095, 32096, 32097, 32098, 32099, 32100, 32101, 32102, 32103, 32104, 32105, 32106, 32108, 32109, 32110, 32111, 32112, 32113, 32114, 32115, 32116, 32117, 32118, 32119, 32120, 32121, 32122, 32123, 32124, 32125, 32126, 32127, 32128, 32129, 32130, 32131, 32132, 32133, 32134, 32135, 32136, 32137, 32138, 32139, 32140, 32141, 32142, 32143, 32144, 32145, 32146, 32147, 32148, 32149, 32150, 32151, 32152, 32153, 32154, 32155, 32156, 32157, 32158, 32159, 32160, 32161, 32162, 32163, 32164, 32165, 32166, 32167, 32168, 32169, 32172, 52023, 52028, 52049, 52073, 320001, 320002, 320003, 320005, 320006, 320008, 320010, 320018, 320019, 320024, 320026, 320029, 320030, 320031, 320033, 320037, 320054, 320058, 320059, 320069, 320073, 320074, 320078, 320079, 320080, 320081, 320082, 320083, 320084, 320088, 320090, 320092, 320096, 320099, 320100, 320101, 320103, 320107, 320111, 320114, 320115, 320119, 320122, 320123, 320125, 320126, 320128, 320129, 320131, 320132, 320133, 320134, 320136, 320138, 320144, 320146, 320147, 320200, 320201, 320202, 320203, 320204, 320206, 320207, 320208, 320209, 320210, 320211, 320212, 320213, 320214, 320215, 320216, 320217, 320218, 320219, 320220, 320221, 320222, 320223, 320224, 320225, 320226, 320227, 320228, 320229, 320230, 320231, 320232, 320233, 320234, 320235, 320236, 320237, 320238, 320239, 320240, 320241, 320242, 320243, 320245, 320246, 320247, 320248, 320250, 320251, 320252, 320253, 320254, 320255, 320256, 320257, 320258, 320260, 320261, 320262, 320263, 320264, 320265, 320266, 320267, 320268, 320269, 320270, 320271, 320272, 320273, 320274, 320275, 320276, 320277, 320278, 320279, 320280, 320282, 320283, 320284, 320286, 320287, 320294, 320298, 320301, 320307, 320310, 320311, 320312, 320313, 320330, 320334, 320336, 320338, 320339, 320340, 320341, 320343, 336011, 336012, 336013, 336015, 336016, 336017, 336018, 336023, 336025, 336027, 336028, 336029, 336034, 336040, 336044, 336046, 336051, 336059, 336060, 336064, 336066, 336067, 336068, 336069, 336070, 336071, 336072, 336073, 336075, 336076, 336077, 336078, 336079, 336080, 336081, 336082, 336083, 336085, 336086, 336087, 336088, 336089, 336090, 336091, 336092, 336093, 336094, 336095, 336096, 336097, 336098, 336099, 336100, 336101, 336102, 336103, 336104, 336105, 336106, 336107, 336108, 336109, 336110, 336111, 336112, 336113, 336114, 336115, 336116, 336117, 336118, 336119, 336120, 336122, 336123, 336124, 336125, 336126, 336127, 336128, 336129, 336130, 336131, 336132, 336133, 336134, 336135, 336136, 336137, 336138, 336139, 336140, 336141, 336142, 336143, 336144, 336145, 336146, 336147, 336148, 336149, 336150, 336151, 336152, 336153, 336154, 336155, 336156, 336157, 336158, 336159, 336160, 336161, 336162, 336163, 336164, 336165, 336166, 336167, 336168, 336169, 336170, 336171, 336172, 336173, 336174, 336175, 336176, 336177, 336178, 336179, 336180, 336181, 336182, 336183, 336184, 336185, 336186, 336187, 336188, 336189, 336190, 336191, 336192, 336193, 336194, 336195, 336196, 336197, 336198, 336199, 336200, 336201, 336202, 336203, 336204, 336205, 336206, 336207, 336208, 336209, 336210, 336211, 336212, 336213, 336214, 336215, 336216, 336217, 336220, 336221, 336223, 336224, 336225, 336226, 336227, 336228, 336230, 336231, 336232, 336233, 336235, 336243, 336245, 336247, 336248, 336257, 336259, 336260, 336261, 336262, 336263, 336265, 336267, 336268, 336269, 336270, 336271, 336272 and 336273.

Distribution Pattern:

Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Algeria, Argentina, Australia, Austria, Bangladeshm Belgium, Bolivia, Brazil, Cambodia, Canada, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djbouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Korea, Latvia, Lebanon, Lithuania, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestinian territory, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russian Federation, Rwanda, Saudi Aarabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated