PlainRecordsFDA · Medical device recall
GE Healthcare… and 2 more products
- Date posted by the FDA
- May 26, 2010
- Status
- Terminated
- Filed by
- Ge Healthcare, Llc
- Reason
- A potential software failure related to the Worklist functionality has been identified on a subset of Innova 2100IQ, 3100IQ and 4100IQ systems. When using the Worklist function to import patient data to Innova, there are two scenarios that will cause the next exam to fail and the inability to recall acquired sequences.
- Distribution pattern
- Worldwide distribution: USA, Puerto Rico, VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, PROVINCE OF CHINA, SWEDEN, SPAIN, RUSSIAN FEDERATION, ROMANIA, POLAND, PHILIPPINES, NORWAY, NETHERLANDS, MOROCCO, REPUBLIC OF KOREA, KAZAKSTAN, JAPAN, ITALY, ISLAMIC REPUBLIC OF IRAN, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CHINA, CHILE, CANADA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ARGENTINA.
3 products in this recall
GE Healthcare…
- Product
- GE Healthcare, Innova 4100 IQ: GE Innova 4100 / 4100 IQ., Cardiovascular Imaging System (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
- Quantity
- 28
- Codes and lots
- 0000009C2M0037 0000009C2M0007 00000008C2M001 0000009C2M0032 0000009C2M0154 0000009C2M0065 0000009C2M0072 0000009C2M0078 0000009C2M0084 0000009C2MOO84 0000009C2M0085 0000009C2M0143 0000009C2M0136 0000009C2M0163 0000009C2M0100 0000009C2M0162 0000009C2M0117 0000009C2M0167 0000009C2M0093 0000009C2M0166 0000009C2M0171 0000009C2M0187 0000009C2M0144 0000009C2M0106 0000009C2M0199 0000009C2M0200 0000010C2M0005 0000009C2M0024
- Recall started
- March 24, 2010
- Device type
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Root cause (FDA)
- Software design
- What the company told customers
- Consignees were sent on 3/24/10, a GE Healthcare " Urgent Medical Device Correction" letter dated March 23, 2010. The letter included the Safety Issue, Affected Product Details, Product Correction and Contact Information.
- Recall number
- Z-1659-2010
GE Healthcare…
- Product
- GE Healthcare, Innova 3100 IQ : GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
- Quantity
- 75
- Codes and lots
- 0000008C2M0006 0000008C2M0003 0000009C2M0029 0000009C2M0014 0000009C2M0028 0000009C2M0057 0000009C2M0049 0000009C2M0013 0000009C2M0040 0000009C2M0025 0000009C2M0023 0000009C2M0041 0000009C2M0021 0000009C2M0046 0000009C2M0033 0000009C2M0058 0000009C2M0053 0000009C2M0056 0000009C2M0060 0000009C2M0150 0000009C2M0062 0000009C2M0009 0000009C2M0030 0000009C2M0064 0000009C2M0054 0000009C2M0042 0000009C2M0068 0000009C2M0059 0000009C2M0010 0000009C2M0016 0000009C2M0074 0000009C2M0096 0000009C2M0088 0000009C2M0090 0000009C2M0104 0000009C2M0077 0000009C2M0063 0000009C2M0148 0000009C2M0101 0000009C2M0067 0000009C2M0157 0000009C2M0156 0000009C2M0175 0000009C2M0111 0000009C2M0120 0000009C2M0128 0000009C2M0127 0000009C2M0131 0000009C2M0130 0000009C2M0147 0000009C2M0097 0000009C2M0110 0000009C2M0118 0000009C2M0192 0000009C2M0119 0000009C2M0160 0000009C2M0177 0000009C2M0205 0000009C2M0209 0000010C2M0011 0000009C2M0071 0000009C2M0178 0000009C2M0185 0000009C2M0082 0000009C2M0081 0000009C2M0126 0000009C2M0122 0000009C2M0180 0000009C2M0197 0000009C2M0109 0000009C2M0112 0000009C2M0115 0000010C2M0002 0000010C2M0006 0000009C2M0139
- Recall started
- March 24, 2010
- Device type
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Root cause (FDA)
- Software design
- What the company told customers
- Consignees were sent on 3/24/10, a GE Healthcare " Urgent Medical Device Correction" letter dated March 23, 2010. The letter included the Safety Issue, Affected Product Details, Product Correction and Contact Information.
- Recall number
- Z-1660-2010
GE Healthcare…
- Product
- GE Healthcare, Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
- Quantity
- 92
- Codes and lots
- 0000009C2M0012 0000008C2M0005 0000009C2M0019 0000009C2M0017 0000009C2M0008 0000009C2M0015 0000009C2M0027 0000008C2M0002 0000009C2M0020 0000009C2M0048 0000009C2M0038 0000009C2M0050 0000009C2M0022 0000009C2M0051 0000009C2M0052 0000009C2M0011 0000009C2M0045 0000009C2M0086 0000009C2M0034 0000009C2M0073 0000009C2M0080 0000009C2M0066 0000009C2M0087 0000009C2M0070 0000009C2M0055 0000009C2M0061 0000009C2M0047 0000009C2M0091 0000009C2M0075 0000009C2M0031 0000009C2M0102 0000009C2M0094 0000009C2M0095 0000009C2M0103 0000009C2M0121 0000009C2M0069 0000009C2M0141 0000009C2M0135 0000009C2M0123 0000009C2M0159 0000009C2M0098 0000009C2M0146 0000009C2M0018 0000009C2M0153 0000009C2M0168 0000009C2M0145 0000009C2M0107 0000009C2M0142 0000009C2M0203 0000009C2M0114 0000009C2M0129 0000009C2M0170 0000009C2M0169 0000009C2M0182 0000009C2M0044 0000009C2M0125 0000009C2M0190 0000009C2M0201 0000009C2M0152 0000009C2M0140 0000009C2M0184 0000010C2M0001 0000009C2M0039 0000009C2M0035 0000009C2M0036 0000009C2M0043 0000009C2M0132 0000009C2M0151 0000009C2M0164 0000009C2M0172 0000009C2M0196 0000009C2M0207 0000009C2M0183 0000009C2M0206 0000009C2M0113 0000009C2M0105 0000009C2M0191 0000009C2M0174 0000009C2M0137 0000009C2M0133 0000009C2M0134 0000009C2M0138 0000009C2M0161 0000009C2M0181 0000009C2M0198 0000010C2M0016 0000009C2M0089 0000009C2M0204 0000009C2M0079 0000009C2M0186 0000009C2M0165 0000009C2M0076
- Recall started
- March 24, 2010
- Device type
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Root cause (FDA)
- Software design
- What the company told customers
- Consignees were sent on 3/24/10, a GE Healthcare " Urgent Medical Device Correction" letter dated March 23, 2010. The letter included the Safety Issue, Affected Product Details, Product Correction and Contact Information.
- Recall number
- Z-1661-2010
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1659-2010, Z-1660-2010, Z-1661-2010. The agency record governs; check it and the company before acting.