PlainRecordsFDA · Medical device recall
GE Precision MPi… and 2 more products
- Date posted by the FDA
- Sept. 19, 2008
- Status
- Terminated
- Filed by
- GE Healthcare
- Reason
- The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
- Distribution pattern
- Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,
3 products in this recall
GE Precision MPi…
- Product
- GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
- Quantity
- 54 (24 US / 30 OUS)
- Codes and lots
- serial numbers: 507001, 507002, 507003, 507004, 507005, 507006, 507007, 507008, 510001, 510002, 510003, 510004, 510005, 510006, 510007, 510008, 510009, 510010, 513001, 513002, 513004, 513005, 513006, 513007, 513008, 513009, 513010, 513011, 518002, 518003, 518004, 518005, 518006, 518007, 518008, 518009, 518010, 518011, 518012, 518013, 518014, 518015, 518016, 518017, 518018, 518019, 518020, 522001, 522002, 522003, 522004, 522005, 522006, and 522008.
- Recall started
- May 1, 2008
- Device type
- System, X-Ray, Fluoroscopic, Image-Intensified
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- GE Field Engineers visited affected customers to make the correction.
- Recall number
- Z-2142-2008
GE Precision MPi…
- Product
- GE Precision MPi, model 2385125. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
- Quantity
- 54 (24 US / 30 OUS)
- Codes and lots
- to follow
- Recall started
- May 1, 2008
- Device type
- System, X-Ray, Fluoroscopic, Image-Intensified
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- GE Field Engineers visited affected customers to make the correction.
- Recall number
- Z-2143-2008
GE Precision MPi…
- Product
- GE Precision MPi, model 2398238. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
- Quantity
- 54 (24 US / 30 OUS)
- Codes and lots
- to follow
- Recall started
- May 1, 2008
- Device type
- System, X-Ray, Fluoroscopic, Image-Intensified
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- GE Field Engineers visited affected customers to make the correction.
- Recall number
- Z-2144-2008
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-2142-2008, Z-2143-2008, Z-2144-2008. The agency record governs; check it and the company before acting.