GE Healthcare, LLC recalls Service manuals for the CT, PET, or NM table as follows: GT1

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Following are the service manual revision numbers and the GTINs for the associated systems: (1) Service manual identifier 5193754-800, Rev 23 and prior, GTIN: N/A; (2) Service manual identifier 5307450-2EN, Rev 30 and prior, GTIN: Revolution Discovery CT: 00840682102490; Revolution Discovery CT A: 00840682125574; Revolution HD: N/A; Discovery CT750 HD: N/A; Discovery 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; Optima 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, GTIN: 00195278563408. (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; Revolution Maxima US: 00840682147392; Revolution Ace: 00840682146159; Optima CT680 Expert: 008406821469372; Revolution 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, GTIN: 00840682146173. (16) Service manual identifier 5307450-2EN, Rev 30 and prior, GTIN: Revolution Discovery CT: 00840682102490; Revolution Discovery CT A: 00840682125574; Revolution HD: N/A; Discovery CT750 HD: N/A; Discovery 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; Revolution Maxima US: 00840682147392; Revolution Ace: 00840682146159; Optima CT680 Expert: 008406821469372; Revolution 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, GTIN: 00840682137553. (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; Discovery MI non-weldment: 00840682108218; Discovery MI Gen2: 00195278098603. NOTE: Discovery MI has three different GTINs to identify different versions of the device. (22) Service manual identifier 5146686-2EN, Rev 7 and prior, GTIN: Discovery MI-DR non-weldment: 00840682120975; Discovery MI-DR weldment: 00840682146166. NOTE: Discovery MI-DR has two different GTINs to identify different versions of the device. (23) Service manual identifier 5495002-2EN, Rev 11 and prior, GTIN: 00840682125703. (24) Service manual identifier 5428822-2EN, Rev 5 and prior, GTIN: Discovery 610: 00840682103053; Discovery 710: 00840682102995. (25) Service manual identifier 5440658-2EN, Rev 5 and prior, GTIN: Discovery 610: 00840682103053; Discovery 710: 00840682102995; Optima 560: N/A. (26) Service manual identifier 5322777-2EN, Rev 12 and prior, GTIN: Discovery 600 Upgrade: 00840682143981; Discovery 690 Elite: N/A; Optima 560: N/A. (27) Service manual identifier 5266353-2EN, Rev 14 and prior, GTIN: N/A. (28) Service manual identifier 5193574-800, Rev 36 and prior, GTIN: 00840682105286. (29) Service manual identifier 5193574-800, Rev 36 and prior, GTIN: N/A. (30) Service manual identifier 5866660-8EN, Rev 26 and prior, GTIN: 00840682109796. (31) Service manual identifier 5987660-8EN, Rev 3 and prior, GTIN: 00840682146173. (32) Service manual identifier 5307450-2EN, Rev 30 and prior, GTIN: Revolution Discovery CT: 00840682102490; Revolution Discovery CT A: 00840682125574; Revolution HD: N/A. (33) Service manual identifier 5796213-2EN, Rev 8 and prior, GTIN: 00840682137553. (34) Service manual identifier 5366080-8EN, Rev 39 and prior, GTIN: Optima CT660 Cj2.5 Upgrade: 00840682116510. (35) Service manual identifier 5866660-8EN, Rev 26 and prior, GTIN: 00840682109796. (36) Service manual identifier 5987660-8EN, Rev 3 and prior, GTIN: 00840682146173. (37) Service manual identifier 5116374, Rev 21 and prior, GTIN: N/A. (38) Service manual identifier 2326233, Rev 17 and prior, GTIN: N/A. (39) Service manual identifier 5661743-2EN, Rev 9 and prior, GTIN: Discovery MI weldment: 00840682143523; Discovery MI non-weldment: 00840682108218; Discovery MI Gen2: 00195278098603. NOTE: Discovery MI has three different GTINs to identify different versions of the device. (40) Service manual identifier 5146686-2EN, Rev 7 and prior, GTIN: Discovery MI-DR non-weldment: 00840682120975; Discovery MI-DR weldment: 00840682146166. NOTE: Discovery MI-DR has two different GTINs to identify different versions of the device. (41) Service manual identifier 5495002-2EN, Rev 11 and prior, GTIN: 00840682125703. (42) Service manual identifier 5428822-2EN, Rev 5 and prior, GTIN: Discovery 610: 00840682103053; Discovery 710: 00840682102995. (43) Service manual identifier 5440658-2EN, Rev 5 and prior, GTIN: Discovery 610: 00840682103053; Discovery 710: 00840682102995; Optima 560: N/A. (44) Service manual identifier 5322777-2EN, Rev 12 and prior, GTIN: Discovery 600 Upgrade: 00840682143981; Discovery 690 Elite: N/A; Optima 560: N/A. (45) Service manual identifier 5266353-2EN, Rev 14 and prior, GTIN: N/A. (46) Service manual identifier 5366638-8EN, Rev 24 and prior, GTIN: Discovery RT: 00840682118699, Discovery CT590RT; Optima CT580: N/A. (47) Service manual identifier 5196837-800, Rev 12 and prior, GTIN: N/A. (48) Service manual identifier 5478834-1EN, Rev 6 and prior, GTIN: N/A. (49) Service manual identifier 5458022-8EN, Rev 15 and prior, GTIN: N/A (50) Service manual identifier 5487206-8EN, Rev 8 and prior, GTIN: Revolution ACT: 00840682135313; Revolution ACT LMB: 00840682146197, Revolution ACT EL: 00195278568373, Revolution ACTs: 00195278534811; Revolution Star: N/A; Revolution Star ES: N/A; ACT: N/A; ACTs: N/A. (51) Service manual identifier 2244773, Rev 36 and prior, GTIN: N/A. (52) Service manual identifier 5181178-800, Rev 24 and prior, GTIN: N/A. (53) Service manual identifier 5411810-8EN, Rev 10 and prior, GTIN: Optima CT520: 00840682102568. (54) Service manual identifier 5457941-8EN, Rev 16 and prior, GTIN: Optima CT520: 00840682102568; Optima Advance: 00840682147415. (55) Service manual identifier 5836560-8EN, Rev 2 and prior, GTIN: 00195278563408. (56) Service manual identifier 5366080-8EN, Rev 39 and prior, GTIN: Optima CT660 Cj2.5 Upgrade: 00840682116510. (57) Service manual identifier 5487410-8EN, Rev 14 and prior, GTIN: N/A. (58) Service manual identifier 5809950-8EN, Rev 3 and prior, GTIN: Revolution Maxima: 00840682146180; Revolution Maxima US: 00840682147392; Revolution Ace: 00840682146159; Optima CT680 Expert: 008406821469372; Revolution Maxima M: N/A. NOTE: Revolution Maxima has two different GTINs to identify different versions of the device. (59) Service manual identifier 5850006-8EN, Rev 1 and prior, GTIN: Revolution Advance: 00195278385215; Revolution Eagle: 00195278403087. (60) Service manual identifier 2188543, Rev 44 and prior, GTIN: N/A. (61) Service manual identifier 2244773, Rev 36 and prior, GTIN: N/A.