GE Medical Systems Information Technologies, Inc.

How does FDA spell GE Medical Systems Information Technologies, Inc.?

FDA publishes this company under 10 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Showing 8 of 10.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does GE Medical Systems Information Technologies, Inc. file in?

34 product codes, ranked by how much they file in each.

Showing the 25 they file in most, of 34.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has GE Medical Systems Information Technologies, Inc. had a recall?

openFDA lists 24 recall records naming this company across its whole history, of which 9 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

• Z-2878-2026Open, ClassifiedMWI10 July 2026

  Portrait Core Services Software version V1.2.0 Security Vulnerability

• Z-2876-2026Open, ClassifiedDPS29 June 2026

  Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.

• Z-2242-2026Class IIOpen, ClassifiedMHX24 April 2026

  GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

• Z-2243-2026Class IIOpen, ClassifiedMHX24 April 2026

  GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

• Z-2244-2026Class IIOpen, ClassifiedMHX24 April 2026

  GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

Showing the 5 most recently initiated of 24.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has GE Medical Systems Information Technologies, Inc. cleared recently?

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Where is GE Medical Systems Information Technologies, Inc. registered?

FDA lists 3 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.