Reported Aug 17, 2022 · Ongoing
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Service manuals for the CT, PET
- or NM table as followsGT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems
- Lot codes and dates
49 of 49 products
Products covered by this recall Model / number Barcodes Product as published — (1) Service manual identifier 5193754-800, Rev 23 and prior, GTIN: N/A — 00840682102490(2) Service manual identifier 5307450-2EN, Rev 30 and prior, GTIN: Revolution Discovery CT: 00840682102490 — 00840682125574Revolution Discovery CT A: 00840682125574 — Revolution HD: N/A — Discovery CT750 HD: N/A — 00840682102551Discovery CT: N/A. NOTE: Revolution Discovery CT has two different GTINs to identify different versions of the device. (3) Service manual identifier 5350500-8EN, Rev 28 and prior, GTIN: Optima CT540: 00840682102551 00195278563408.00840682138963001952785634080084068211651000840682146180Optima CT540 N: 00840682138963. Note: Optima CT540 has two different GTINs to identify different versions of the device. (4) Service manual identifier 5836560-8EN, Rev 2 and prior, (5) Service manual identifier 5366080-8EN, Rev 39 and prior, GTIN: Optima CT660 Cj2.5 Upgrade: 00840682116510. (6) Service manual identifier 5487410-8EN, Rev 14 and prior, GTIN: N/A. (7) Service manual identifier 5809950-8EN, Rev 3 and prior, GTIN: Revolution Maxima: 00840682146180 — 00840682147392Revolution Maxima US: 00840682147392 — 00840682146159Revolution Ace: 00840682146159 — Optima CT680 Expert: 008406821469372 00840682146173.00195278420893008406821375530084068211869900840682105286008406821097960084068214617300840682102490Revolution Maxima M: N/A. (8) Service manual identifier 5848536-8EN, Rev 1 and prior, GTIN: 00195278420893. (9) Service manual identifier 5796213-2EN, Rev 8 and prior, GTIN: 00840682137553. (10) Service manual identifier 5366638-8EN, Rev 24 and prior, GTIN: Discovery RT: 00840682118699, Discovery CT590RT and CT580: N/A. (11) Service manual identifier 5196837-800, Rev 12 and prior, GTIN: N/A. (12) Service manual identifier 5193574-800, Rev 36 and prior, GTIN: 00840682105286. (13) Service manual identifier 5193574-800, Rev 36 and prior, GTIN: N/A. (14) Service manual identifier 5866660-8EN, Rev 26 and prior, GTIN: 00840682109796. (15) Service manual identifier 5987660-8EN, Rev3 and prior, (16) Service manual identifier 5307450-2EN, Rev 30 and prior, GTIN: Revolution Discovery CT: 00840682102490 — 00840682125574Revolution Discovery CT A: 00840682125574 — Revolution HD: N/A — Discovery CT750 HD: N/A — 0084068211651000840682146180Discovery CT: N/A. NOTE: Revolution Discovery CT has two different GTINs to identify different versions of the device. (17) Service manual identifier 5366080-8EN, Rev 39 and prior, GTIN: Optima CT660 Cj2.5 Upgrade: 00840682116510. (18) Service manual identifier 5809950-8EN, Rev 3 and prior, GTIN: Revolution Maxima: 00840682146180 — 00840682147392Revolution Maxima US: 00840682147392 — 00840682146159Revolution Ace: 00840682146159 — Optima CT680 Expert: 008406821469372 00840682137553.0084068213755300840682143523Revolution Maxima M: Not applicable. NOTE: Revolution Maxima has two different GTINs to identify different versions of the device. (19) Service manual identifier 5796213-2EN, Rev 8 and prior, (20) Service manual identifier 5196837-800, Rev 12 and prior, GTIN: N/A. (21) Service manual identifier 5661743-2EN, Rev 9 and prior, GTIN: Discovery MI weldment: 00840682143523 — 00840682108218Discovery MI non-weldment: 00840682108218 - Amount recalled
- 24,843 tables
Where it was sold
Why it was recalled
As a result of unclear guidance in the service manual, the table can drop during a specific service activity if the wrong screws are removed by the service personnel without the appropriate table supports in place resulting in injury to service personnel.
This product could cause temporary or reversible health problems — stop using it.
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